BEUDAMED
    Product Code: JAK FDA class 2 21 CFR 892.1750

    System, X-Ray, Tomography, Computed

    Radiology

    A computed tomography X-ray system, commonly known as a CT scanner, uses a rotating X-ray source and detector array to acquire cross-sectional images of the body, which are reconstructed by computer into detailed anatomical slices used for diagnosis, treatment planning, and monitoring. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JAK, regulated under 21 CFR 892.1750, within the Radiology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    796
    FEI Numbers
    164
    Registration Numbers
    164
    Unique Applicants
    245
    Years Active
    49

    Basic Information

    Product Code
    JAK
    Device Class
    FDA class 2
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 796 510(k) clearances via K numbers.

    K Number Device Name
    K250822 SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
    K250648 Philips iCT CT system
    K243398 CT Scanner TSX-501R/1 V11.1
    K243672 CardIQ Suite
    K250370 SCENARIA View Phase 5.0
    K244008 Spectral CT
    K243617 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
    K250650 SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
    K243240 Vitrea CT VScore
    K242811 BodyTom 64
    K242411 Brainomix 360 e-Lung
    K243523 NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
    K243229 Bunkerhill AVC
    K241166 uCT 550
    K241200 SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
    K241079 uCT 780
    K241757 syngo.CT Dual Energy
    K242403 Aquilion ONE (TSX-308A/3) V1.5
    K242188 ClearRead CT CAC
    K242874 Gating Reflector Block
    K240844 Spectral CT 7500 RT
    K240369 CAC (gated) Algorithm
    K241295 SOMATOM On.site
    K241440 HealthCCSng
    K233731 CardIQ Suite
    K241713 HiRise (1040-230)
    K233767 OmniTom Elite
    K233875 Brainomix 360 e-Lung
    K232491 CT 5300
    K233583 FCT iSTREAM Phase 1
    K233698 True Enhance DL
    K232227 ABLATE-IQ
    K233750 ECG-less Cardiac
    K232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
    K233657 NAEOTOM Alpha
    K233650 SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
    K233753 AI-Rad Companion (Pulmonary)
    K232022 CAS-One IR
    K233749 Revolution Ascend Sliding
    K233080 HealthFLD
    K234030 Clear Guide SCENERGY
    K232412 LungQ v3.0.0
    K232136 syngo.CT Applications
    K233334 Aquilion Serve SP (TSX-307B/1) V1.3
    K232206 SOMATOM Pro.Pulse
    K232155 syngo.CT Dual Energy
    K231482 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
    K231631 BriefCase-Quantification
    K232392 CT Lung Ventilation Analysis Software (CT:V)
    K232045 MeVis Liver Suite
    K230370 SpotLight/SpotLight Duo (with DLIR option)
    K231574 Scenaria View 4.2
    K230220 NeuViz 128 Multi-Slice CT Scanner System
    K230130 Micromate™ Navi+
    K231281 Aquilion Serve (TSX-307A/1) V1.3
    K230162 uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
    K223424 Spine Auto Views
    K223261 Open Rib
    K230421 SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
    K230112 CAC Software
    K223447 OmniTom Elite
    K223758 Epione
    K230223 iCAC Device
    K230807 Deep Learning Image Reconstruction
    K222360 AI-Rad Companion (Cardiovascular)
    K223514 Spectral Bone Marrow
    K223726 Aquilion Precision (TSX-304A/4) V10.14 with AiCE
    K222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
    K223028 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
    K223804 PercuNav Image Fusion and Interventional Navigation System
    K223311 Philips CT 3500
    K213465 CardioGraphe
    K222361 AI-Rad Companion (Musculoskeletal)
    K213759 XACT Robotic System, ACE Model
    K220986 Aquilion Precision (TSX-304A/4) V10.10 with AiCE
    K220910 Medical image processing software
    K213713 AI-Rad Companion (Pulmonary)
    K220961 Deep Learning Image Reconstruction
    K221727 syngo.CT Extended Functionality
    K220814 NAEOTOM Alpha, Scan&GO Software
    K213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
    K213829 SCENARIA View
    K221219 syngo.CT CaScoring
    K221116 XACT ACE Robotic System
    K212875 Spectral CT on Rails
    K220664 NewTom 7G
    K211180 Liver Suite
    K213649 BodyTom 64
    K212441 Philips Incisive CT
    K213944 HealthOST
    K212889 Syngo.CT Dual Energy
    K213725 CardIQ Suite
    K220450 syngo.CT Applications
    K211711 OmniTom Elite
    K211645 Epione
    K213999 Deep Learning Image Reconstruction
    K213938 Revolution Ascend
    K214019 syngo.CT Extended Functionality
    K213927 Respiratory Gating for Scanners v2.0
    K210760 Precise Image
    K213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
    K213096 Al-Rad Companion (Pulmonary)
    K211168 Philips Incisive CT on Trailer
    K211591 NAEOTOM Alpha, Scan&GO
    K212067 Deep Learning Image Reconstruction
    K210085 HealthCCSng
    K211828 Aquilion Exceed LB
    K212494 Lung Image Analysis
    K211373 SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software
    K203448 uCT ATLAS with uWS-CT-Dual Energy Analysis
    K203411 syngo.CT Skull Unfolding
    K203720 MICROMATE
    K203514 Precise Position
    K203699 syngo. CT Extended Functionalities
    K203225 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
    K203617 MaxFOV 2
    K203020 Spectral CT
    K200626 VesselIQ Xpress
    K201231 CTxx85 CT Scanner
    K201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
    K202526 OmniTom Elite
    K203042 Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
    K201745 Deep Learning Image Reconstruction for Gemstone Spectral Imaging
    K203216 The Multimodality Advanced Vessel Analysis
    K203169 Revolution Ascend
    K203187 HiRise
    K193289 FastStroke, CT Perfusion 4D
    K201092 LSN
    K202213 syngo.CT Neuro Perfusion
    K201188 Clear Guide SCENERGY
    K200990 VIDAvision
    K201898 Clear Guide SCENERGY
    K193277 SOMATOM On.site and On.scene
    K200498 SCENARIA View
    K201586 XACT Robotic System
    K193073 Deep Recon
    K201053 PercuNav Image Fusion and Interventional Navigation
    K201034 Syngo.CT CaScoring
    K193293 XV Lung Ventilation Analysis Software
    K200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
    K200515 syngo.CT Cardiac Planning
    K193281 Hepatic VCAR
    K193267 Al-Rad Companion (Musculoskeletal)
    K192590 CURA 778
    K191550 Broncholab
    K200016 uCT 530, uCT 550
    K192832 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
    K192828 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
    K193454 IQon Spectral CT
    K192956 Auto Positioning
    K192763 syngo.CT CaScoring
    K193170 Deep Learning Image Reconstruction
    K192061 SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
    K191891 SOMATOM X.cite
    K192686 Revolution Maxima, Revolution Ace
    K192427 Ablation Confirmation
    K191332 XACT Robotic System
    K192402 syngo.CT Extended Functionality
    K190841 SCENARIA View
    K183268 AI-Rad Companion (Cardiovascular)
    K192188 Aquilion ONE (TSX-306A/3) V10.0
    K191394 ILLUMISITE Platform
    K191136 Access CT
    K191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
    K183271 AI-Rad Companion (Pulmonary)
    K182901 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
    K191468 syngo.CT Dual Energy
    K190578 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
    K183046 Aquilion ONE (TSX-305A/6) V8.9 with AiCE
    K190505 Low Dose Lung Screening Option
    K182716 Brain Perfusion (BP) application
    K183548 SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
    K183202 Deep Learning Image Reconstruction
    K183204 Bone VCAR (BVCAR)
    K183448 NewTom 5G XL
    K183161 SnapShot Freeze 2
    K183291 Supria True64 Whole-Body X-Ray CT System
    K183143 uCT 520, uCT 528
    K181646 Celesteion, PCA-9000A/3, V6.5
    K173076 CURA 16; ScintCare CT16
    K182223 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
    K182147 CTXX85
    K181414 uCT 530, uCT 550
    K181797 Philips CT Big Bore Sliding Gantry Configuration
    K172983 HealthCCS
    K173821 LungQ Software
    K180901 Low Dose CT Lung Cancer Screening Option
    K180727 LineUp
    K180225 GSI Viewer with GSI Fat Option
    K162314 IMACTIS CT-Navigation system
    K173632 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
    K173637 syngo.CT Coronary Analysis; syngo.CT Vascular Analysis
    K173630 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
    K173607 SOMATOM Edge Plus
    K180015 Philips Incisive CT
    K180393 AIRO Computed Tomography (CT) X-ray System
    K173625 syngo.CT Clinical Extensions
    K172135 uCT Computed Tomography X-ray System
    K173468 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
    K172058 CT6485, CT12885
    K173244 superDimension Navigation System V7.2
    K173478 OnSight 3D Extremity System
    K171677 Clear Guide SCENERGY
    K171198 NeuViz 16 Essence Multi-slice CT Scanner System
    K172539 CereTom Elite
    K163643 SIRIO H3
    K171850 Philips CT Big Bore
    K172188 Aquilion Prime SP, TSX-303B/1, v8.4
    K171201 NeuViz Prime Multi-slice CT Scanner System
    K171738 Supria True64
    K171261 ScannerSide DoseCheck
    K171183 OmniTom
    K170177 Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
    K170238 BodyTom Elite
    K171013 Revolution ACT
    K170023 SPiN Thoracic Navigation System
    K171022 Ablation Confirmation
    K170789 In Reach
    K170273 Z-DOSE29
    K170716 PercuNav Image Fusion and Interventional Navigation
    K170221 syngo.CT Cardiac Planning
    K162838 Philips iCT CT System
    K163711 IQon Spectral CT
    K163297 Scan&GO
    K163296 SOMATOM go.Up, SOMATOM go.Now
    K163528 HITACHI Supria Whole-body X-ray CT System Phase 3
    K163284 syngo. CT Neuro Perfusion
    K163341 syngo.CT Extended Functionality
    K163289 syngo. CT Single Source Dual Energy (twin beam)
    K170019 Aquilion Lightning, TSX-036A/1, V8.4
    K163281 FastStroke
    K163213 Revolution CT
    K162302 Somatom Confidence ® RT Pro
    K161157 Vitrea CT Dual Energy Image View
    K160723 OnSight 3D Extremity System
    K161196 SOMATOM Drive
    K161748 SUPRIA w/guideShot Option
    K161066 SpotLight CT
    K160743 Philips Ingenuity CT
    K160611 P-ARTIS
    K161009 Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
    K161285 Ablation Confirmation
    K153360 ADMIRE
    K160350 ECG CT Gating Device
    K160587 Aquilion ONE (TSX-305A/3) V7.3
    K153331 SafeCT-29
    K160126 AIRO Computed Tomography (CT) X-ray System
    K153444 Philips Multislice CT System with Low Dose CT Lung Cancer
    K153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0
    K151765 SOMATOM Perspective
    K151749 somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
    K153429 SmartView 3D Option
    K153220 syngo.CT Single Source Dual Energy (Twin Beam)
    K153004 Clear Guide SCENERGY
    K152584 Stroke VCAR
    K152473 CAS-One IR
    K151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
    K142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
    K151414 IQQA Guide
    K151752 SOMATOM Emotion 6/16
    K151376 superDimension Navigation System
    K151383 NeuViz 128 Multi-slice CT Scanner System
    K150713 syngo.CT Myocardial Perfusion
    K151283 Lung Analysis Software
    K150595 SCENARIA Phase 3 Whole-body X-ray CT System
    K151919 Vitrea CT Lung Density Analysis Software
    K152036 SOMATOM Definition Edge, SOMATOM Definition AS/AS+
    K151833 Aquilion Lightning (TSX-035A/2, V7.0)
    K150565 Supria Whole-body X-ray CT System
    K151372 Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
    K151533 Respiratory Gating for Scanners
    K150757 syngo.CT Dual Energy
    K150745 syngo.CT Single Source Dual Energy
    K150665 Philips Spectral CT Applications
    K150785 syngo.CT Dental
    K143294 Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
    K150104 Vitrea CT Myocardial Perfusion
    K143416 SOMATOM Definition Flash (VA48)
    K143400 SOMATOM Definition AS/AS+
    K143401 SOMATOM Definition Edge
    K143409 SOMATOM Definition AS Open (VA48)
    K150003 Aquilion LB, TSX-201A/3, V6.0
    K142465 Aquilion ONE Vision, v7.0
    K142222 NewTom 5G
    K142584 iMAR
    K143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
    K142697 NExCT 7
    K133373 CLEARVIEW
    K141741 AQUILION PRIME, V6.00
    K133674 PHILIPS IQON SPECTRAL CT
    K133643 SYNGO, CT LIVER ANALYSIS
    K133677 SYNGO CT SINGLE SOURCE DUAL ENERGY
    K133603 PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
    K141069 Lung Density Analysis
    K140912 SOMATOM SCOPE/SOMATOM SCOPE POWER
    K134025 AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
    K133324 SURESUBTRACTION LUNG
    K140232 SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
    K133648 SYNGO, CT DUAL ENERGY
    K133901 PARI-PATH SURGICAL NAVIGATION SYSTEM
    K133646 ADMIRE
    K132524 CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
    K132108 MAXIO
    K133590 SOMATOM PERSPECTIVE
    K133649 HEPATIC VCAR
    K133589 SOMATOM FORCE
    K133705 REVOLUTION CT
    K132902 SYNGO DUAL ENERGY SOFTWARE PACKAGE
    K133640 ASIR-V
    K131433 ISYS 1 (U.S),ACCESSORY, NON-STERILE
    K133497 AQUILION ONE VISION
    K132813 DUAL ENERGY SYSTEM PACKAGE
    K133424 SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
    K132410 DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
    K130552 CT PULMONARY ANALYSIS
    K130901 SOMATOM DEFINITION AS OPEN
    K132523 MYOPERFUSION
    K132222 AQUILION ONE VISION, V6.0
    K131431 AIRO CT SYSTEM
    K131773 BRILLIANCE ICT
    K131576 OPTIMA CT660
    K123540 SYNGO CT PULMO 3D
    K130960 SURESUBTRACTION ORTHO
    K132087 PERCUNAV SYSTEM
    K130224 ICT
    K123576 IMR SOFTWARE APPLICATION
    K130645 AQUILION PRIME, V5.00
    K123500 AQUILION LB TRITON V4.91
    K123541 SYNGO.CT NEURO PERFUSION
    K123509 SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
    K123584 SYNGO, CT BONE READING
    K123596 OPTIMA CT520
    K121418 PLANMED VERITY
    K122909 SYNGO SINGLE SOURCE DUAL ENGERY
    K122106 SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
    K123585 SYNGO, CT CARDIAC FUNCTION
    K121498 PERCUNAV
    K121792 NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
    K120796 SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
    K113483 ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
    K122109 AQUILION ONE VISION, V4.90
    K121827 GSI VIEWER WITH VUE OPTION
    K122471 SOMATOM DEFINITION
    K113715 LUNG VOLUME ANALYSIS
    K121553 AQUILION RXL
    K113421 MINICAT
    K120910 CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
    K120546 AQUILION PREMIUM
    K120833 DISCOVERY CT750 HD
    K120579 SOMATOM DEFINITION EDGE
    K113287 SOMATOM PERSPECTIVE
    K121072 SOMATOM DEFINITION FLASH
    K113732 IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
    K113341 GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
    K120331 SYNGO CT DYNAMIC ANGIO
    K120300 CT-GUIDE NEEDLE GUIDANCE SYSTEM
    K113548 PEDCAT
    K113466 AQUILION ONE
    K112989 AQUILION CXL
    K120710 AQUILION PRIME
    K110066 AQUILION PRIME
    K113342 SOMATOM DEFINITION FLASH
    K103424 SAFIRE
    K113063 CT-GUIDE NEEDLE GUIDANCE SYSTEM
    K103489 GE VEO RECONSTRUCTION OPTION
    K111633 AQUILION LB MOVEMENT BASE KIT
    K112020 SYNGO.CT VASCULAR ANALYSIS
    K110227 OPTIMA CT660
    K110812 CT-GUIDE NEEDLE GUIDANCE SYSTEM
    K093581 DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
    K110366 SYNGO.CT CARDIAC FUNCTION
    K101888 SCENARIA WHOLE-BODY X-RAY CT SYSTEM
    K102677 BODYTOM NL 4000
    K102102 COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K103127 SOMATOM DEFINITION AS
    K102259 DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K110093 SUPERDIMENSION MARKER DELIVERY KIT
    K093891 AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
    K102604 I-LOGIC INREACH SYSTEM
    K091529 ICAD VERALOOK CTC CAD SOFTWARE
    K093810 BF-NAVI
    K100637 SYNGO.CT CORONARY ANALYSIS
    K093787 IGUIDE CAPPA
    K093995 IG 4 IMAGE GUIDED SYSTEM
    K091934 IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
    K093146 IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
    K092747 PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
    K090991 COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
    K092742 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
    K092365 INREACH SYSTEM, MODEL AAS00161-02
    K092013 SYNGO VOLUME PERFUSION-CT BODY
    K091673 GE LIGHTSPEED ACT FP16
    K090462 BRILLIANCE DUAL ENERGY OPTION
    K091103 GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
    K091195 PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
    K083524 SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
    K090504 CSBP-001A BODY PERFUSION SYSTEM
    K090220 COLON VIEW, MODEL CSCV-001A
    K090173 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
    K083498 PHILIPS MODEL MX 16 SLICE CT SYSTEM
    K083282 MODEL TSX-301B AQUILION CT SYSTEM
    K083293 VIATRONIX V3D-CARDIAC, REVISION 1.0
    K083227 VIDA PULMONARY WORKSTATION 2 (PW2)
    K082960 GE XTREME INJECTOR OPTION
    K082458 P3T ABDOMEN
    K080581 VB IMAGE VIEWER
    K082220 SOMATOM FLASH DS
    K082816 GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
    K082761 GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
    K082104 GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
    K081847 PICASSO MASTER, ECT AND MASTER 3D
    K081482 CSBP-001A BODY ORGAN PERFUSION SYSTEM
    K081379 MODIFICATION TO INREACH SYSTEM
    K081022 SOMATOM DEFINITION, MODEL AS/AS+
    K081105 GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
    K080624 NAVSTATIONIRAD EMT, VERSION 1.1
    K073695 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
    K080271 INREACH SYSTEM
    K073346 ZIEHM VISION 2
    K080211 MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
    K080540 NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
    K073153 CARDIQ FUNCTION XPRESS
    K073138 CARDIQ EXPRESS VERSION 2.0
    K073003 SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
    K073238 SYNGO VOLUME PERFUSION-CT NEURO
    K073373 SYNGO VOLUME PERFUSION-CT BODY
    K072693 CSNP-001A NEURO PACKAGE
    K072574 ALPHARD CONE BEAM CT, MODEL X178
    K072841 NEUVIZ SPIRAL CT SCANNER SYSTEM
    K072737 CSCS-001A CALCIUM SCORING PACKAGE
    K072606 AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
    K071806 ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K071308 MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
    K071513 INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
    K071378 MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
    K071310 SYNGO CT ONCOLOGY SOFTWARE PACKAGE
    K070658 DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
    K063324 PET VCAR
    K063762 SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
    K063507 SYNGO NEURO PBV CT
    K063241 CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
    K063189 TSX-301A, AQUILION ONE CT SYSTEM
    K063184 MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
    K063029 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
    K062386 QANGIO CT
    K062351 SYNGO DUAL ENERGY
    K062451 NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
    K062673 MODIFICATION TO SYNGO INSPACE 4D
    K062315 SUPERDIMENSION/BRONCHUS PREMIUM 2
    K061834 XCAT; XCAT FOR NEURO
    K061449 SYNGO EXPERT-1
    K061817 LIGHTSPEED 7.1 CT SCANNER SYSTEM
    K061310 ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
    K061625 AUTOBONE2
    K060937 BRILLIANCE VOLUME
    K061370 CARDIQ FUSION
    K061187 TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
    K060903 IG4 IMAGE GUIDED SYSTEM
    K060052 GE LIGHTSPEED XTRA CT SCANNER SYSTEM
    K053610 ABARIS
    K060779 ADVANCE VESSEL ANALYSIS II
    K052839 CT PERFUSION 4
    K053148 CXR16
    K053210 MAYFIELD SCANMATE MOBILE CT SYSTEM
    K052587 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
    K052852 SUPERDIMENSION/BRONCHUS PREMIUM
    K053046 ILUMA ORTHOCAT/DENTALCAT
    K053024 SYNGO NEURO DSA CT
    K052855 STARSPEED SERIES CT SCANNER SYSTEMS
    K052447 SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
    K052260 SUPERDIMENSION/BRONCHUS 4.1
    K052216 SOMATOM DEFINITION
    K052157 INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
    K051980 DVT SCANNER
    K052029 SYNGO CIRCULATION
    K051833 TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER
    K051765 CERETOM, MODEL NL3000
    K050867 SYNGO BODY PERFUSION-CT
    K050458 TSX-201A AQUILION LB CT SCANNER
    K050297 SOMATOM EMOTION 16
    K043469 SYNGO INSPACE 4D
    K043086 SOMATOM RESPIRATORY GATING
    K043087 SOMATOM CARE CONTRAST CT
    K043111 PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
    K042438 SUPERDIMENSION/BRONCHUS
    K042328 SOMATOM SPIRIT
    K042293 BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
    K042229 SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
    K040782 N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
    K041521 VOLUME VIEWER PLUS
    K041542 CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
    K041267 CARDIQ ANALYSIS III
    K040902 HITACHI PRESTO
    K040224 CADIMPLANT
    K040665 SOMATOM SENSATION 64 AND SENSATION CARDIAC
    K040577 SOMATOM PROJECT P30L
    K033774 CT-MASS
    K040372 LIGHTSPEED 7.0 CT SCANNER SYSTEM
    K033677 BRAIN PERFUSION OPTION
    K033357 ACQSIM-MULTISLICE-CT, MODEL 453567042271
    K033832 SYNGO PERFUSION-CT
    K033502 LIGHTSPEED 6.0 CT SCANNER SYSTEM
    K033418 TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
    K032823 MEDICHEART, MODEL RELEASE 1
    K032536 SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
    K032475 SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
    K033102 MEDIC COLON MODEL, RELEASE 1
    K032915 ADVANTAGE 4D OPTION
    K033326 PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
    K032243 MINICAT DENTOCAT
    K031871 AUTOBONE
    K031469 AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
    K031206 RADIOMED SOFT TISSUE MARKER
    K031261 CARD EP
    K030450 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
    K023943 CT COLONOGRAPHY
    K030420 LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
    K024171 VIDAR BONE TRACK SYSTEM SOFTWARE
    K024149 PRIMELUNG
    K023785 LUNG NODULE ASSESSMENT AND COMPARISON OPTION
    K022326 RADIOMED MARKER
    K023760 CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
    K023687 SOMATOM EMOTION 6 CT SYSTEMS
    K023332 LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
    K022794 E-SPEED EBT SCANNER SYSTEM
    K022919 SMART BREATH RESPIRATORY COMPENSATION OPTION
    K022239 SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
    K022354 ULTRAGUIDE CTG 2000SA
    K013999 LODOX, MODEL BASELINE
    K022013 LUNGCARE CT SOFTWARE PACKAGE
    K022050 CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
    K021491 HISPEED DUAL
    K020929 SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
    K020913 CT-C3000 SPIRAL CT SCANNER SYSTEM
    K020796 CARD IQ ANALYSIS II
    K014240 PRONTO
    K020385 CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
    K013146 VIATRONIC V3D CALCIUM SCORING
    K013561 LIGHTSPEED 4.0 CT SCANNER SYSTEM
    K013522 SOMATOM P30 CT SYSTEMS
    K013521 GEMINI IMAGING SYSTEM
    K013422 CARDIQ FUNCTION
    K013381 ADVANCED LUNG ANALYSIS-1
    K013214 CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
    K012238 DOSERIGHT
    K012106 ACCUIMAGE SMARTGATE UPGRADE
    K012009 MX8000 IDT CT SYSTEM
    K012836 MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
    K012385 HISPEED X/I SMART GANTRY OPTION
    K012313 CT COLONOGRAPHY/NAVIGATOR2
    K011447 IN SPACE 3D
    K011141 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
    K011180 CT/MASTER, VERSION 1.0
    K010817 MX8000 V5.0 CT SYSTEM
    K011160 E-Z EM PERCUPUMP 2001 CT INJECTOR
    K010813 SIMPLICT
    K010641 GE CT-PET SYSTEM
    K010042 CT PERFUSION 2
    K003639 VITREA 2 CT PERFUSION OPTION
    K003736 MRI LINE MARKER
    K003230 V SCORE WITH AUTO GATE MODEL TBD
    K003408 CT CORD IQ OPTION 1.0
    K003152 SOMATOM SMILE
    K003014 SOMATOM EMOTION MS
    K002978 LIGTHSPEED 3.0 CT SCANNER SYSTEM
    K002005 BOLUSPRO ULTRA
    K002258 ULTRAGUIDE CT-GUIDE 1010
    K001682 VSCORE WITH EKG SIGNAL GATING
    K001088 ULTRASIM CT SYSTEM
    K000819 PHILIPS CT SECURA MV
    K994431 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
    K000359 EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO
    K000300 LIGHTSPEED 2.0CT SCANNER SYSTEM
    K993645 CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
    K993792 SMART VESSEL ANALYSIS (SMART VA) OPTION
    K993791 CT PERFUSION OPTION
    K992740 EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS
    K991764 SOMATOM PROJECT 10-CT SCANNERS
    K991766 ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
    K991716 HISPEED NX/I CT SCANNER SYSTEM
    K991600 SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
    K991553 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
    K991278 PHILIPS TOMOSCAN AV-NT
    K990426 CALCIUM SCORING
    K984156 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
    K990134 MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)
    K984634 3D-ANGIO
    K982536 PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
    K982010 FACTS
    K983140 CT BIOPSYVIEW
    K982787 ASTEION CT SCANNER, TSX-021A
    K982631 PHILIPS TOMOSCAN CS
    K982583 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
    K982349 SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
    K982060 VOLUMAX CT IMAGING SYSTEM
    K982265 AQUILION CT SCANNER, MODEL TSX-101A
    K982004 CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
    K974715 ADVANTAGE 3D XR
    K974344 CT SCOPE
    K980837 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
    K974513 PINPOINT
    K980176 HISPEED QX/I CT SCANNER SYSTEM
    K980169 HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
    K974455 ANATOM 1000 (A MINUS, A-)
    K974307 RTR-2000/RTR-4000
    K973908 AUKLET CT SCANNER, TSX-003A
    K973168 SMARTVIEW OPTIONS FOR HISPEED CT/I
    K972903 IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
    K972879 ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION
    K973329 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
    K973327 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
    K972399 ADVANTAGE WINDOWS VOLUME RENDERING OPTION
    K971717 FLY THROUGH
    K970819 TARGOBEAM
    K971054 OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
    K970980 CARDIAC SCORING FOR CT SCANNERS
    K970999 SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
    K970606 COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K965004 C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
    K964890 ANATOM 2000
    K964747 SOMATOM PLUS 4 CT SCANNER
    K964746 HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
    K964583 XRT-7.0
    K964318 PHILIPS TOMOSCAN AV EXPANDER UPGRADE
    K963896 MOBILE CT PROSPEED FAMILY
    K960985 SLS-CT
    K961464 SELECT/SP
    K961055 CT PROSPEED CT/I
    K955583 VIFS
    K950972 REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
    K960635 PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS
    K955255 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
    K955268 PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K955254 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
    K955253 SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
    K935454 DPX TISSUE QUANTIFICATION OUTPUT
    K954255 PHILIPS TOMOSCAN SR 8000
    K943623 PQ5000 CT SYSTEM
    K945512 HRSW OPTION FOR CT TWIN FLASH
    K944013 CT PROSPEED FAMILY
    K944131 ANATOM 2000
    K944983 MEDRAD COUNTERPOISE SYSTEM
    K944326 PHILIPS TOMOSCAN SR5000
    K936272 PHILIPS TOMOSCAN SR 4000
    K941546 SOMATOM PROJECT 059
    K940606 HISPEED ADVANTAGE II
    K941745 TSX-002A (XVISION) CT SCANNER
    K932508 ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
    K942040 MRX-280
    K935487 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF
    K923524 VOLUMETRIC RENDERING TECHNIQUE OPTION
    K924985 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
    K932848 SIMULIX-MC CT EXTENSION
    K934832 IMPAX 3000
    K930765 ULTRA COMPACT VIDEO IMAGER
    K930090 HELICAT
    K924082 PHILIPS TOMOSCAN SR7000 CT SYSTEMS
    K923077 ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
    K924810 SIM/PLANT
    K921192 CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
    K923114 HEAD RESTRAINT FOR CT TABLES
    K923111 ARM EXTENDER FOR CT TABLES
    K923110 SCAN BAND
    K923109 ADULT CHIN STRAP FOR CT TABLES
    K923108 WRIST RESTRAINT FOR GE9800 C.T. TABLES
    K923106 SCAN BAND
    K915738 EXCEL CT TWIN
    K921432 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
    K914305 SYTEC DENTASCAN
    K915623 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
    K913485 CT SYTEC 8000
    K913352 C-150 ULTRAFAST CT SCANNER
    K913996 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
    K913029 GYROVIEW-HR
    K912454 KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
    K911764 IMAC2000
    K913491 VORTECH'S PERSONAL DISPLAY SYSTEM
    K912752 PHILIPS TOMOSCAN SR
    K913252 LITEBOX
    K911501 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
    K911500 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
    K910859 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
    K911387 CT SYTEC 4000
    K910375 HELICAL SCAN
    K904971 CT HILIGHT ADVANTAGE II
    K903701 XPRESS
    K903763 COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K903622 CT GUIDE (TM)
    K902557 XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K902848 FASTRECON 88 PERIFERAL
    K900170 MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
    K902643 FALCON DISK DRIVE SUBSYSTEM
    K900660 TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
    K896456 TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K900233 TCT-300S - UPGRADE
    K894888 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
    K894887 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
    K894542 ELSCINT'S EXEL 2400E CT SCANNER
    K894269 CT HILIGHT ADVANTAGE
    K893820 CT SYTEC 3000
    K891931 QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
    K884788 TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
    K884555 TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
    K885322 3D/DENTAL
    K884671 EXEL 2400 AND 2400 ELITE CT SCANNERS
    K884670 EXEL 1800 AND 1800E CT SCANNER
    K884669 EXEL 2002 & 2002FS CT SCANNER
    K884668 EXEL 1002 CT SCANNER
    K884667 EXEL 905 SERIES CT SCANNER
    K884268 VOXELSCOPE(TM)
    K881305 TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
    K882378 P-7 COMPUTED TOMOGRAPHY SYSTEM
    K881674 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
    K882906 DENTASCAN
    K882581 CT MAX 640 #B7940 JA/JE
    K882022 TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM
    K875088 XENON CT
    K875370 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
    K880965 SOMATOM PLUS
    K880822 PICS-2000
    K874767 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11
    K872615 IMATRON C-100 ULTRAFAST CT SCANNER
    K872526 CT PACE CATALOG NUMBER B7950A
    K872150 I.S.G. 3DMV WORKSTATION
    K871859 CT9800 QUICK 3D #B7919DA
    K870513 CSI/3D
    K863935 TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
    K864046 C-IOO MOBILE CINE CT UNIT
    K862317 CT MAX, CATALOG NO. B7940 HA
    K861698 VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400
    K861708 SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
    K854340 TECHNICARE 720 HPS CT SCANNER
    K853444 TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
    K852865 OPTICAL DISC UNIT
    K844926 HEAD-SPINE STABILIZER HSS-1
    K850027 MEDITECH EUROSCANNER M250
    K843927 CT 9000
    K841997 CT 9800
    K840860 CENTAURI CT SCANNER
    K833228 INSTANT IMAGER
    K820688 ARRANGE TM
    K813196 IMAGE ANALYSIS CENTER
    K813162 INTERAD WHOLE BODY CT SCANNER
    K812509 CT/T 8800
    K812393 4001 CT SCANNER
    K812410 DELTASCAN 2060 CT SCANNER
    K812400 OMNIMEDICAL QUAD I
    K812241 CT/T 9800
    K811723 WHOLE BODY SCANNER
    K811227 CT/T DATALINK-B7875 AA/B7875 AB
    K811358 DEHYDRATED BILE
    K803181 SCANNER, COMPUTERIZED TOMOGRAPHIC
    K802206 OMNI SCANNER CT 6000
    K802045 G.E. SCAN CAPABILITY CAT.#B7815F
    K801446 PFIZER PZ-CT SCANNER
    K801407 SYNERVIEW MODEL 6545
    K792603 COMPUTED TOMOGRAPHY X-RAY SCANNER
    K791163 PFIZER 0200FS LOCALLZER
    K791153 ACTA-SCANNER 0220FS
    K791195 DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN
    K790975 SOMATOM 2
    K790942 RADVIEW IMAGER SYSTEM
    K790395 VIDICAM VIDEO REPROGRAPH
    K790342 SOMATOM SD
    K790134 RADIOTHERAPY TREATMENT
    K781936 SCANNER-EMI 7020 AND 7020R
    K781752 SCANNER, CT 0450
    K781431 ELECTRIC CT/T OPERATOR DISPLAY CONSOLE
    K781040 CT SCANNER ND 8000
    K780930 5543 INDEPENDENT VIEWING SYSTEM
    K780928 CT5137 HIGH RESOLUTION OPTION
    K780769 S-100 CT SCANNER
    K780737 CT BLANKETS (BOLUS MATERIAL)
    K780480 CT/T INDEPENDENT DIAGNOSTIC CENTER
    K780326 GE CT/T 8800 SYSTEM
    K780115 SCANNERS, TOMOGRAPHIC, COMPUTED
    K772317 CT/T SYSTEM MODEL B7800A
    K772305 RAD. THERAPY PLANNING SUP. SYS.
    K772291 DIAG. CONSOLE, INDEPENDENT
    K772289 SCANNER, CT, 0400
    K772198 CT SCANNER DIAGNOSTIC CONSOLE, REMOTE
    K771990 OMNIMEDICAL 400L
    K771978 CTR 100L
    K772125 TOMOGRAPHIC SCANNER, COMPUTERIZED
    K772123 TOMOGRAPHIC SYSTEM, COMPUTERIZED
    K771811 EMI CTR 100
    K771082 DELTASCAN 2000 SERIES
    K770855 SYNERVIEW MODEL 6478
    K770573 ACTA-SCANNER R 0200FS
    K761332 HI-SENSITIVITY MODE OPTION FOR S60-1A
    K761330 SYNTEX SYSTEM 6000
    K761033 COMPUTERIZED TOMOGRAPHY SCANNER
    K760882 GE CT/T MODEL NO. B7800 A
    K760808 PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
    K760688 CT/N-II SCANNER SYSTEM
    K760201 X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC

    FEI Numbers

    This FDA classification entry is associated with 164 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 164 registration numbers. Click on an entry to view related FDA registrations.