System, X-Ray, Fluoroscopic, Image-Intensified
An image-intensified fluoroscopic X-ray system uses an electronic image intensifier to amplify the fluoroscopic image, enabling real-time visualization of dynamic processes such as contrast studies, catheterizations, and interventional procedures at reduced radiation doses. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JAA, regulated under 21 CFR 892.1650, within the Radiology medical specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- JAA
- Device Class
- FDA class 2
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 298 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242488 | Soteria E-View | Jan 06, 2025 | Substantially Equivalent | Omega Medical Imaging, LLC |
| K242948 | Adora DRFi (04550010) | Dec 23, 2024 | Substantially Equivalent | NRT X-Ray A/S |
| K233380 | TRIDENT Mobile Fluoroscopy System | Jun 26, 2024 | Substantially Equivalent | Dornier MedTech America |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Jan 11, 2024 | Substantially Equivalent | Philips Medical Systems DMC GmbH |
| K232910 | CombiDiagnost R90 | Oct 19, 2023 | Substantially Equivalent | Philips Medical Systems DMC GmbH |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Sep 12, 2023 | Substantially Equivalent | Canon Medical Systems Corporation |
| K220871 | Nautilus | Apr 18, 2022 | Substantially Equivalent | Dornier MedTech America, Inc |
| K212890 | Nyquist.IQ | Dec 13, 2021 | Substantially Equivalent | Omega Medical Imaging, LLC |
| K212837 | ProxiDiagnost N90 | Sep 21, 2021 | Substantially Equivalent | Philips Medical Systems DMC GmbH |
| K212145 | DR 800 with DSA, DR 800 | Aug 31, 2021 | Substantially Equivalent | Agfa N.V. |
| K210469 | Insight Agile DRF | Jul 27, 2021 | Substantially Equivalent | Imaging Engineering, LLC |
| K203428 | Ziehm Vision RFD | Mar 17, 2021 | Substantially Equivalent | Ziehm Imaging GmbH |
| K203010 | Platinum dRF Imaging System | Jan 22, 2021 | Substantially Equivalent | Apelem-DMS Group |
| K200965 | XR-MX/1000 | Dec 29, 2020 | Substantially Equivalent | KARL STORZ Endoscopy America, Inc. |
| K203087 | CombiDiagnost R90 | Dec 03, 2020 | Substantially Equivalent | Philips Medical Systems DMC GmbH |
| K202235 | ArtPIX DRF | Sep 03, 2020 | Substantially Equivalent | CMT Medical Technologies Ltd |
| K200396 | Insight Enhanced DRF Digital Imaging System | Mar 06, 2020 | Substantially Equivalent | Imaging Engineering, LLC |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Oct 04, 2019 | Substantially Equivalent | Omega Medical Imaging, LLC |
| K191504 | PowerDR | Aug 16, 2019 | Substantially Equivalent | Radiology Information Systems, Inc. |
| K191877 | FLUOROspeed | Aug 05, 2019 | Substantially Equivalent | Shimadzu Corporation |
| K191310 | Insight Essentials DRF Digital Imaging System | Jun 10, 2019 | Substantially Equivalent | Imaging Engineering, LLC |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Mar 29, 2019 | Substantially Equivalent | Omega Medical Imaging, LLC |
| K190373 | SonialVision G4 | Mar 15, 2019 | Substantially Equivalent | SHIMADZU corporation |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | May 21, 2018 | Substantially Equivalent | General Medical Merate S.P.A |
| K180651 | Uroview FD II | Apr 12, 2018 | Substantially Equivalent | Pausch Medical GmbH |
| K180589 | DR 800 with MUSICA Dynamic | Apr 05, 2018 | Substantially Equivalent | Agfa HealthCare N.V. |
| K163210 | Philips CombiDiagnost R90 | Jan 31, 2017 | Substantially Equivalent | Philips Medical Systems DMC GmbH |
| K161019 | Uroview FD | Aug 17, 2016 | Substantially Equivalent | PAUSCH MEDICAL GMBH |
| K160301 | Platinum dRF Imaging System | Mar 04, 2016 | Substantially Equivalent | Apelem-DMS Group |
| K150306 | D2RS_AT Digital Dynamic Remote System | Oct 10, 2015 | Substantially Equivalent | STEPHANIX RADIOLOGICAL SOLUTIONS |
| K151485 | GENESIS | Jun 30, 2015 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Mar 06, 2015 | Substantially Equivalent | SHIMADZU CORP. |
| K133434 | GENESIS II | Nov 26, 2014 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K140380 | OPERA SWING | Sep 26, 2014 | Substantially Equivalent | GENERAL MEDICAL MERATE S.P.A. |
| K141541 | XIDF-AWS801, ANGIO WORKSTATION, V5.31 | Sep 08, 2014 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K132289 | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM | Jun 16, 2014 | Substantially Equivalent | GEMSS MEDICAL SYSTEMS CO. LTD |
| K133553 | KALARE | Jun 13, 2014 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Mar 28, 2014 | Substantially Equivalent | SHIMADZU CORP. |
| K131766 | PLATINUM DRF IMAGING SYSTEM | Dec 12, 2013 | Substantially Equivalent | APELEM-DMS GROUP |
| K132904 | ZIEHM VISION RFD | Dec 05, 2013 | Substantially Equivalent | ZIEHM IMAGING GMBH |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | Nov 12, 2013 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K130318 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) | Apr 22, 2013 | Substantially Equivalent | VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | Feb 13, 2013 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K122768 | GENESIS | Jan 18, 2013 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K121293 | CS-SERIES-FP WITH 3030+OPTION | Jul 26, 2012 | Substantially Equivalent | OMEGA MEDICAL IMAGING, LLC |
| K112054 | INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V | Aug 05, 2011 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
| K111292 | LUMINOS AGILE | Jun 03, 2011 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K110785 | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM | May 27, 2011 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
| K103038 | DUET DRF | Mar 29, 2011 | Substantially Equivalent | CMT MEDICAL TECHNOLOGIES, LTD. |
| K101491 | UROSKOP OMNIA | Jun 30, 2010 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K082830 | INFX-8000H, INFINIX-I | Oct 10, 2008 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K081621 | INFX-8000C (INFINIX CC-I AND VC-I) | Jun 23, 2008 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K081491 | SMITH & NEPHEW CDS SYSTEM | Jun 19, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K081582 | INFX-8000V, INFINIX-CFI AND INFINIX VFI | Jun 17, 2008 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K081091 | PRECISION 500D R&F X-RAY SYSTEM | Jun 11, 2008 | Substantially Equivalent | GE HEALTHCARE |
| K080859 | DRF 4343 | Jun 04, 2008 | Substantially Equivalent | VILLA SISTEMI MEDICALI S.P.A. |
| K070390 | FLUOROPRO RF DIGITAL IMAGING SYSTEM | Apr 05, 2007 | Substantially Equivalent | VIRTUAL IMAGING, INC. |
| K061028 | PRECISION THUNIS 800+ | Jun 07, 2006 | Substantially Equivalent | GE MEDICAL SYSTEMS, LLC |
| K052610 | IMAGE STAR II | Nov 30, 2005 | Substantially Equivalent | LAKESHORE TECHNOLOGIES INC. |
| K051602 | AXIOM SIRESKOP SD | Jul 07, 2005 | Substantially Equivalent | SIEMENS MEDICAL SYSTEMS, INC. |
| K051136 | SMITH & NEPHEW CDS SYSTEM | Jul 01, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K051025 | FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | May 13, 2005 | Substantially Equivalent | HOLOGIC, INC. |
| K050866 | CENTRION 500 C-ARM SYSTEM | Apr 27, 2005 | Substantially Equivalent | OSTEOSYS CO., LTD. |
| K050692 | FLXIS | Apr 08, 2005 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
| K042698 | UNFORS PATIENT SKIN DOSIMETER (PSD) | Oct 22, 2004 | Substantially Equivalent | UNFORS INC. |
| K040870 | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS | May 17, 2004 | Substantially Equivalent | SHIMADZU CORP. |
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM | Mar 20, 2003 | Substantially Equivalent | GE OEC MEDICAL SYSTEMS |
| K022911 | MODEL AMI1200 C-ARM | Dec 02, 2002 | Substantially Equivalent | INTEGRITY PRACTICE MANAGEMENT, INC. |
| K022899 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 | Nov 22, 2002 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
| K022565 | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 | Oct 08, 2002 | Substantially Equivalent | STEREOTAXIS, INC. |
| K021021 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS | Jun 06, 2002 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K020055 | PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION | Mar 15, 2002 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS |
| K012424 | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM | Oct 18, 2001 | Substantially Equivalent | SHIMADZU CORP. |
| K010772 | ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM | Aug 23, 2001 | Substantially Equivalent | IMAGING SERVICES, INC. |
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM | Jun 08, 2001 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K010392 | ATHENA REMOTE CONTROLLED RF SYSTEM | Mar 12, 2001 | Substantially Equivalent | CARES BUILT, INC. |
| K010187 | KIMAX, MODEL 1024 | Feb 14, 2001 | Substantially Equivalent | MEDICAL METRICS, INC. |
| K004037 | X-RAY SYSTEM XR-MX | Feb 02, 2001 | Substantially Equivalent | KARL STORZ ENDOSCOPY |
| K000987 | VFSS IMAGER, MODEL SIS-300 | Jun 01, 2000 | Substantially Equivalent | LIFECARE IMAGING INTL., LTD. |
| K993896 | MCA-601, C-ARM MOBILE | Mar 27, 2000 | Substantially Equivalent | MEDISON RADIOLOGY SYSTEMS, INC. |
| K992603 | XRT 600 R/F, WRF 0600 | Oct 25, 1999 | Substantially Equivalent | WUESTEC MEDICAL, INC. |
| K993038 | TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) | Oct 07, 1999 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | Feb 02, 1999 | Substantially Equivalent | OMEGA MEDICAL IMAGING, INC. |
| K982319 | CAREGRAPH | Sep 22, 1998 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K982345 | VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM | Sep 01, 1998 | Substantially Equivalent | CARDIAC MARINERS, INC. |
| K981414 | LC POSITIONER | Jul 16, 1998 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K982028 | FLUOROSPOT COMPACT | Jul 14, 1998 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K981227 | SYMPHONY 360 REMOTE CONTROL TABLE | Jun 30, 1998 | Substantially Equivalent | ACOMA MEDICAL IMAGING, INC. |
| K974058 | FS IV MINI C-ARM SYSTEM | Jan 12, 1998 | Substantially Equivalent | HOLOGIC, INC. |
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | Dec 29, 1997 | Substantially Equivalent | XRE CORP. |
| K973067 | DRTS REMOTE CONTROL DRAPE | Oct 16, 1997 | Substantially Equivalent | MINRAD, INC. |
| K973073 | DRTS IMAGE INTENSIFIER DRAPE | Oct 08, 1997 | Substantially Equivalent | MINRAD, INC. |
| K972442 | CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 | Sep 11, 1997 | Substantially Equivalent | CONTINENTAL X-RAY CORP. |
| K970947 | B-350 CEILING MOUNTED C-POSITIONER | May 14, 1997 | Substantially Equivalent | OMEGA MEDICAL IMAGING, INC. |
| K970608 | EVT MARKER BOARD | Apr 21, 1997 | Substantially Equivalent | GUIDANT CARDIAC AND VASCULAR SURGERY |
| K961782 | BIO-BINKI | Mar 28, 1997 | Substantially Equivalent | BIOMNI MEDICAL SYSTEMS, INC. |
| K964990 | HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) | Feb 26, 1997 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K964322 | VIPOR UNIT | Feb 26, 1997 | Substantially Equivalent | TILANE CORP. |
| K963888 | C-ARM TABLE IVS-100 | Dec 18, 1996 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K963617 | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 | Nov 08, 1996 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K961140 | FLUOROPLUS CARDIAC TV | Sep 20, 1996 | Substantially Equivalent | CMT MEDICAL TECHNOLOGIES, LTD. |
| K953974 | CAMVISION 1000 | Sep 09, 1996 | Substantially Equivalent | MEDIVISION MEDICAL IMAGING, LTD. |
| K961207 | EP-X BIPLANE | Aug 20, 1996 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K962606 | TOPOGRAPHIC IMAGING MARKER | Aug 07, 1996 | Substantially Equivalent | I.Z.I. MEDICAL PRODUCTS CORP. |
| K962140 | ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 | Jul 25, 1996 | Substantially Equivalent | CONTINENTAL X-RAY CORP. |
| K961690 | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 | Jun 27, 1996 | Substantially Equivalent | CONTINENTAL X-RAY CORP. |
| K961193 | FULL FRAME ZOOM SYSTEM | Jun 17, 1996 | Substantially Equivalent | XRE CORP. |
| K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | Jun 03, 1996 | Substantially Equivalent | CONTOUR FABRICATORS OF FLORIDA, INC. |
| K953113 | SBDX MOBILE FLUOROSCOPY SYSTEM | Mar 29, 1996 | Substantially Equivalent | CARDIAC MARINERS, INC. |
| K951261 | DFI-1000 AND DVS-475 IMAGING DEVICES | Mar 15, 1996 | Substantially Equivalent | NICAL |
| K960266 | SIREGRAPH CF | Mar 11, 1996 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K954945 | HANEL MAVIG MONITOR SUSPENSION SYSTEM | Jan 29, 1996 | Substantially Equivalent | F. WALTER HANEL GMBH |
| K954590 | MAX-1000A/R1 | Nov 20, 1995 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K953950 | FLUORO CATHETER | Sep 18, 1995 | Substantially Equivalent | CMT MEDICAL TECHNOLOGIES, LTD. |
| K952493 | FLUORECORD MODEL 762 | Jun 22, 1995 | Substantially Equivalent | SYRACUSE SCIENTIFIC, INC. |
| K952456 | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM | Jun 16, 1995 | Substantially Equivalent | FISHER IMAGING CORP. |
| K950781 | COMPACT 7600 | Jun 05, 1995 | Substantially Equivalent | GE DEC MEDICAL SYSTEMS |
| K946081 | FLUOREX DTA-400A | May 24, 1995 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K951358 | SIRESKOP SX | May 15, 1995 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K936236 | SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES | May 11, 1995 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K950683 | ARTHROGRAM TRAY | May 06, 1995 | Substantially Equivalent | SURGICAL TECHNOLOGIES, INC. |
| K943156 | SYSTEM, IMAGE PROCESSING | May 04, 1995 | Substantially Equivalent | IMAGE TECHNOLOGY, INC. |
| K950971 | MOBIL C-ARM, REGURBISHED, VARIOUS MODELS | Apr 11, 1995 | Substantially Equivalent | PRO-TRONICS, INC. |
| K950631 | ID400 SERIES ARMBOARDS | Mar 24, 1995 | Substantially Equivalent | IMAGE DIAGNOSTICS, INC. |
| K945460 | PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION | Mar 14, 1995 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
| K941917 | FLUOROPLUA CARDIAC AND/OR INSTAVIEW | Feb 24, 1995 | Substantially Equivalent | FIDELITY MEDICAL, INC. |
| K942019 | MODEL FP-100 | Feb 01, 1995 | Substantially Equivalent | INTERNATIONAL MEDICAL DESIGNS, INC. |
| K943272 | VISUALIZER 2000 | Dec 27, 1994 | Substantially Equivalent | VF-WORKS, INC. |
| K944973 | NRF SYSTEM | Dec 14, 1994 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K943532 | PANORAMIC CORPORATION HDLX | Dec 07, 1994 | Substantially Equivalent | PANORAMIC CORP. |
| K943447 | V-MAX OPTIONS | Nov 28, 1994 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K943805 | PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD | Sep 23, 1994 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K940295 | UROVIEW MODEL 2600 | Aug 22, 1994 | Substantially Equivalent | GE DEC MEDICAL SYSTEMS |
| K942841 | OEC 901 | Aug 09, 1994 | Substantially Equivalent | BALDWIN |
| K942674 | ANGIOREST TABLE PAD SYSTEM | Jul 29, 1994 | Substantially Equivalent | SCRIBNER BROWNE MEDICAL DESIGN, INC. |
| K942264 | DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) | Jul 20, 1994 | Substantially Equivalent | EIGEN VIDEO |
| K941611 | TDA-4000/A4 | May 13, 1994 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K926560 | EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER | May 09, 1994 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K933472 | SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES | Feb 07, 1994 | Substantially Equivalent | SHIMADZU CORP. |
| K936136 | UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE | Jan 25, 1994 | Substantially Equivalent | GE DEC MEDICAL SYSTEMS |
| K933473 | CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM | Nov 24, 1993 | Substantially Equivalent | SHIMADZU CORP. |
| K933791 | PHILIPS ANGIOPRO RELEASE 2.1 | Nov 22, 1993 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
| K934626 | GOODALL LASER TARGETING DEVICE | Nov 19, 1993 | Substantially Equivalent | PROTECTAIR, INC. |
| K933100 | ARC-600 | Nov 08, 1993 | Substantially Equivalent | B C MEDICAL LTD. |
| K934481 | EP-X | Nov 03, 1993 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K933299 | QL MULTIPULSE 2048 | Nov 03, 1993 | Substantially Equivalent | INFIMED, INC. |
| K932445 | SIRESKOP CX | Sep 07, 1993 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K931941 | SUNSCOPE 100 | Jul 20, 1993 | Substantially Equivalent | SUNNING CORP. |
| K931268 | URETERAL COMPRESSION DEVICE | Jul 19, 1993 | Substantially Equivalent | BT MEDICAL CO., INC. |
| K930885 | PNEUMATIC COMPRESSION DEVICE | Jul 13, 1993 | Substantially Equivalent | BT MEDICAL CO., INC. |
| K926064 | FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A | Apr 27, 1993 | Substantially Equivalent | SCIENTIFIC TECHNOLOGY LTD. |
| K926434 | SIS-300(N)-DIA SCAN | Mar 18, 1993 | Substantially Equivalent | MICRO-FOCUS IMAGING., INC. |
| K926122 | FLUOREX | Feb 12, 1993 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K924879 | EP 3000 | Jan 04, 1993 | Substantially Equivalent | OEC-DIASONICS, INC. |
| K925251 | LIXI IMAGING SCOPE. MODIFICATION | Dec 28, 1992 | Substantially Equivalent | LIXI, INC. |
| K923107 | BODY BAND RESTRAINT STRAP SET | Nov 27, 1992 | Substantially Equivalent | COOK, INC. |
| K922977 | EXPOSET | Nov 27, 1992 | Substantially Equivalent | S & S INFICON, INC. |
| K924164 | DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT | Nov 23, 1992 | Substantially Equivalent | EIGEN |
| K923585 | DIGITAL FLUORO STORE | Oct 21, 1992 | Substantially Equivalent | EIGEN |
| K922274 | MEDRAD PATHFINDER-E ROADMAPPING SYSTEM | Oct 09, 1992 | Substantially Equivalent | MEDRAD, INC. |
| K923454 | SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES | Oct 05, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K923453 | SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES | Oct 05, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K923137 | CSL X-RAY IMAGESCOPE | Sep 23, 1992 | Substantially Equivalent | CSI OPTO-ELECTRONICS CORP. |
| K922240 | ELECTRONIC PHOTOSPOT 20 | Aug 07, 1992 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K920746 | VFC UNIT | Jun 30, 1992 | Substantially Equivalent | TILANE CORP. |
| K922012 | SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES | Jun 16, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K922013 | SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES | Jun 10, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K922011 | SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES | Jun 10, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K920720 | DIGITAL RADIOGRAPHY SYSTEM IDR-1000 | Apr 20, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K920721 | DIGITAL RADIOGRAPHY SYSTEM IDR-2000 | Apr 15, 1992 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K920550 | DISPLAY PROCESSOR - MODEL IDP5100 | Apr 13, 1992 | Substantially Equivalent | PERKINS MFG. CO. |
| K915405 | P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) | Feb 04, 1992 | Substantially Equivalent | PRECISE OPTICS PHOTO MEDIC EQUIPMENT, INC. |
| K914414 | VIDEO FLUOROSCOPE | Jan 24, 1992 | Substantially Equivalent | RAYMAX MEDICAL CORP. |
| K913886 | SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER | Jan 24, 1992 | Substantially Equivalent | SONY MEDICAL ELECTRONICS CO. |
| K915592 | PEGASUS LATERAL CARDIAC POSITIONER | Jan 13, 1992 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K914446 | UROVIEW 2000, MODIFICATION | Jan 10, 1992 | Substantially Equivalent | OEC-DIASONICS, INC. |
| K905694 | FVP-1000 FAMILY AND FVP-1000D FAMILY | Nov 27, 1991 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K914525 | FLUROSPOT H VERSION 2 | Nov 19, 1991 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K913012 | DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES | Sep 23, 1991 | Substantially Equivalent | EIGEN |
| K912896 | DIGISTORE 2100 | Aug 26, 1991 | Substantially Equivalent | ENHANCED IMAGING TECHNOLOGIES, INC. |
| K912341 | MULTICAM I 8X10 | Aug 26, 1991 | Substantially Equivalent | CAMTRONICS, LTD. |
| K912470 | PHILIPS DIAGNOST 96 | Aug 07, 1991 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K912380 | LASER BEAM LOCALIZER FOR SIREMOBIL 4 | Jul 19, 1991 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K911454 | FC2000 | Jul 15, 1991 | Substantially Equivalent | S & S INFICON, INC. |
| K910384 | VIDEO ANNOTATOR MODEL PK2310 | Apr 16, 1991 | Substantially Equivalent | PERKINS MFG. CO. |
| K905278 | STS(TM) FLUOROSCOPIC IMAGING MODULE | Feb 04, 1991 | Substantially Equivalent | MEDSTONE INTL., INC. |
| K905111 | DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES | Jan 25, 1991 | Substantially Equivalent | EIGEN |
| K904986 | PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 | Dec 04, 1990 | Substantially Equivalent | PERKINS MFG. CO. |
| K904012 | PHILIPS INTEGRIS I 2000 SYSTEM | Nov 29, 1990 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K902982 | G.E. POLARIX II C-ARM | Nov 13, 1990 | Substantially Equivalent | ELECTROMEK DIAGNOSTIC SYSTEMS, INC. |
| K903821 | PSC-1 W/OTHER NUMERICAL | Nov 07, 1990 | Substantially Equivalent | EIGEN |
| K902981 | G.E. FLUOROCON 300 IMAGING SYSTEM | Nov 07, 1990 | Substantially Equivalent | ELECTROMEK DIAGNOSTIC SYSTEMS, INC. |
| K902983 | SIEMEN'S SIREMOBILE II C-ARM | Nov 06, 1990 | Substantially Equivalent | ELECTROMEK DIAGNOSTIC SYSTEMS, INC. |
| K902980 | G.E. XT CEILING TUBE SUSPENSION | Oct 23, 1990 | Substantially Equivalent | ELECTROMEK DIAGNOSTIC SYSTEMS, INC. |
| K902583 | JOINT MOTON IMAGER(TM) | Sep 27, 1990 | Substantially Equivalent | CONCORD IMAGING, LTD. |
| K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | Sep 20, 1990 | Substantially Equivalent | OMEGA MEDICAL IMAGING, INC. |
| K901671 | HAFCON (FLOURO FOOTSWITCH) | Aug 08, 1990 | Substantially Equivalent | B & H RESEARCH INSTRUMENTS |
| K902927 | DIGITAL PHOTOSPOT | Aug 03, 1990 | Substantially Equivalent | EIGEN |
| K902535 | SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM | Jun 29, 1990 | Substantially Equivalent | SONY MEDICAL ELECTRONICS CO. |
| K901405 | DIGIFORMER HR DFP-50A | May 07, 1990 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K901323 | HYDRA VIEW IMAGING SYSTEM | Apr 25, 1990 | Substantially Equivalent | MALLINCKRODT GROUP, INC. |
| K901153 | SONY VO-5800H VIDEOCASSETTE RECORDER | Apr 19, 1990 | Substantially Equivalent | SONY MEDICAL ELECTRONICS CO. |
| K900893 | CARDIOVUE CFS-100 | Apr 19, 1990 | Substantially Equivalent | BV MEDICAL EQUIPMENT CO. |
| K896331 | V2465P X-RAY IMAGE INTENSIFIER | Dec 22, 1989 | Substantially Equivalent | HAMAMATSU PHOTONICS, K.K. |
| K895546 | MODIFIED SPANTRON FRAME FREEZE | Nov 13, 1989 | Substantially Equivalent | SPANTRON, INC. |
| K895394 | MOBILE X-RAY TELEVISION UNIT WHA-10A/B | Nov 13, 1989 | Substantially Equivalent | SHIMADZU CORP. |
| K895730 | X-RAY EQUIPMENT (VARIOUS TYPES) | Nov 06, 1989 | Substantially Equivalent | CONTINENTAL X-RAY CORP. |
| K894913 | DA-100HS | Sep 18, 1989 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K893475 | UROVIEW II | Aug 10, 1989 | Substantially Equivalent | OEC-DIASONICS, INC. |
| K893644 | PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER | Aug 09, 1989 | Substantially Equivalent | PERKINS MFG. CO. |
| K893476 | ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. | Jun 23, 1989 | Substantially Equivalent | ANDROS ANALYZERS, INC. |
| K893131 | DIGITAL SPOT IMAGING (DSI) | Jun 06, 1989 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | Apr 20, 1989 | Substantially Equivalent | SHIMADZU PRECISION INSTRUMENTS, INC. |
| K884028 | MULTI CAMERA CONTROL UNIT (MCCU) | Mar 15, 1989 | Substantially Equivalent | LEYBOLD-INFICON, INC. |
| K890878 | PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD | Mar 14, 1989 | Substantially Equivalent | U.S. IMAGING, INC. |
| K890745 | SC-1000 WITH SUFFIXES (SCAN CONVERTER) | Mar 14, 1989 | Substantially Equivalent | EIGEN |
| K884578 | POLARIX 2 AND POLARIX 2E | Feb 09, 1989 | Substantially Equivalent | DYNA-MED |
| K883580 | UNIVERSAL ABC CONTROLER | Jan 09, 1989 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K884317 | MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM | Dec 20, 1988 | Substantially Equivalent | MEDRAD, INC. |
| K883372 | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | Nov 25, 1988 | Substantially Equivalent | AUSONICS PTY LTD. |
| K883985 | CARDIAC CX | Nov 21, 1988 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K883161 | HIMOBILIX 2N | Oct 21, 1988 | Substantially Equivalent | BAY X-RAY, INC. |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | Sep 14, 1988 | Substantially Equivalent | SHIMADZU PRECISION INSTRUMENTS, INC. |
| K882175 | HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP | Aug 19, 1988 | Substantially Equivalent | EIGEN |
| K882176 | VTR-12 | Aug 11, 1988 | Substantially Equivalent | EIGEN |
| K880527 | CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM | Feb 29, 1988 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K874905 | P2020 MOBILE C-ARM IMAGE INTENSIFIER | Feb 26, 1988 | Substantially Equivalent | PHOTO MEDIC EQUIPMENT, INC. |
| K874901 | REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE | Jan 29, 1988 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K875157 | SHIMADZU CATHETERIZATION C-ARM STAND MH-50A | Jan 19, 1988 | Substantially Equivalent | SHIMADZU PRECISION INSTRUMENTS, INC. |
| K873985 | FLUORO COVER | Jan 19, 1988 | Substantially Equivalent | CONDOR MEDICAL |
| K872061 | LP LATERAL FLUORO POSITIONER (B5077A) | Jun 22, 1987 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K871743 | VIDEO PLUS MODELS VP500, VP500A AND VP1000 | Jun 22, 1987 | Substantially Equivalent | CAMTRONICS, LTD. |
| K871911 | THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION | May 29, 1987 | Substantially Equivalent | F. SPOON CO. |
| K871127 | DTV-4112 FLUOROSCOPIC TELEVISION CAMERA | May 01, 1987 | Substantially Equivalent | ADAC LABORATORIES |
| K870869 | DTV-411OP | May 01, 1987 | Substantially Equivalent | ADAC LABORATORIES |
| K871119 | CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D | Mar 31, 1987 | Substantially Equivalent | CANON U.S.A., INC. |
| K863853 | EAZY COVERS | Mar 06, 1987 | Substantially Equivalent | SUPERIOR MEDICAL PRODUCTS |
| K870429 | EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186) | Feb 11, 1987 | Substantially Equivalent | THE MASON CLINIC |
| K864749 | TELAMAT | Feb 10, 1987 | Substantially Equivalent | COMET LTD. C/O RADIOLOGY RESOURCES, INC. |
| K864837 | MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM | Jan 30, 1987 | Substantially Equivalent | OEC-DIASONICS, INC. |
| K864584 | FLUOROVISION CONTRAST ENHANCER | Dec 29, 1986 | Substantially Equivalent | DIGIVISION, INC. |
| K862120 | SCX SYSTEM | Jun 16, 1986 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K861785 | FLUOROSCOPE BAND BAG | Jun 13, 1986 | Substantially Equivalent | MEDI-PLAST INTL., INC. |
| K854953 | DIAMED MODELS 600, 900, 960, 964 | Apr 22, 1986 | Substantially Equivalent | DIAMED DIVISION ILL. TOOL WORKS, INC. |
| K852346 | XISCAN MODEL 1000 | Mar 10, 1986 | Substantially Equivalent | XI TECH |
| K855213 | PET-SCOPE II IMAGE INTENSIFIER | Jan 10, 1986 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K853984 | CANON X-RAY IMAGE DISTRIBUTOR | Oct 16, 1985 | Substantially Equivalent | CANON U.S.A., INC. |
| K851031 | EXPOSCOP MOBILE IMAGING SYSTEM | May 28, 1985 | Substantially Equivalent | EURO-ELECTRONICS, INC. |
| K850959 | EQUIPMENT SNAP KOVERS | Apr 09, 1985 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K844375 | EIGEN FLORO-STOR FS-100 | Mar 26, 1985 | Substantially Equivalent | EIGEN VIDEO |
| K843920 | FLUOROSCAN/TM BY HEALTHMATE | Feb 07, 1985 | Substantially Equivalent | HEALTHMATE, INC. |
| K843972 | ANGIOPLUS-S | Jan 03, 1985 | Substantially Equivalent | OEC-DIASONICS, INC. |
| K843917 | FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL | Jan 03, 1985 | Substantially Equivalent | AFP IMAGING CORP. |
| K843235 | STENOSCOP | Nov 08, 1984 | Substantially Equivalent | CGR MEDICAL CORP. |
| K842217 | IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS | Nov 08, 1984 | Substantially Equivalent | MICRO CONSULTANTS, INC. |
| K842191 | DIGISTORE 50 | Oct 25, 1984 | Substantially Equivalent | VAS CORP. |
| K840621 | FLUOROSCOPIC IMAGE INTENSIFIER | Jun 05, 1984 | Substantially Equivalent | PHOENIX RADIOLOGY, LTD. |
| K840225 | C-ARM CEILING CRANE FT-2 | Mar 22, 1984 | Substantially Equivalent | MEDICOR USA LTD. |
| K840364 | REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY | Mar 19, 1984 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K840191 | DIGITAL FLUOROGRAPHY X-RAY SYSTEM | Mar 16, 1984 | Substantially Equivalent | ADAC LABORATORIES |
| K840134 | CAMTEX 1000 | Mar 16, 1984 | Substantially Equivalent | DIGITAL IMAGING CO. OF AMERICA |
| K840390 | TECHNICARE MODEL 1047 | Feb 21, 1984 | Substantially Equivalent | TECHNICARE CORP. |
| K834287 | DIGITAL RADIOGRAPHY SYS-DPS7100 | Jan 10, 1984 | Substantially Equivalent | ADAC LABORATORIES |
| K834286 | BI-PLANE DIGITAL FLUOROGRAPHY DFX7000 | Jan 04, 1984 | Substantially Equivalent | ADAC LABORATORIES |
| K833641 | IMAGE INTENSIFIER TUBE W/HOUSING & | Dec 30, 1983 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K833531 | CT SCANNING ACCESSORIES | Dec 08, 1983 | Substantially Equivalent | LDS HOSPITAL |
| K833237 | DIGITAL RADIOGRAPHY SYS DUAL GANTRIES | Dec 08, 1983 | Substantially Equivalent | AMERICAN SCIENCE AND ENGINEERING, INC. |
| K833530 | DIGITAL FLUOROGRAPHIC X-RAY SYSTEM | Nov 21, 1983 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K833230 | REGISTREX 1000 DIGITAL RADIOGRAPHY SYS | Nov 21, 1983 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K827489 | HYPERLUX 30 IMAGE SYSTEM | Nov 04, 1982 | Substantially Equivalent | CGR MEDICAL CORP. |
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 04, 1982 | Substantially Equivalent | PRECISE OPTICS |
| K820184 | LATERAL ANGULATING FLUORO SUSPENSION | Feb 24, 1982 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K813158 | RDP-2000 | Jan 19, 1982 | Substantially Equivalent | MACHLETT LABORATORIES, INC. |
| K813217 | DIGITAL FLUROGRAPHIC IMAGING SYSTEM | Dec 29, 1981 | Substantially Equivalent | DIASONICS, INC. |
| K812963 | IBIS II | Nov 24, 1981 | Substantially Equivalent | CGR MEDICAL CORP. |
| K812775 | FLUORICON L300 IMAGE INTENSIFIER | Nov 06, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K812561 | LATERAL ANGULATING FLUORO SUSPENSION SYS | Oct 13, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K812217 | FLUORO AUTOMATIC BRIGHTNESS SYS | Sep 16, 1981 | Substantially Equivalent | KEYSTONE X-RAY, INC. |
| K811094 | CARDIAC 1000 TM | Jul 28, 1981 | Substantially Equivalent | AMERICAN EDWARDS LABORATORIES |
| K811295 | DIGITAL NOISE REDUCER | Jun 23, 1981 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K810716 | X-RAY IMAGE INTENSIFIER PRODUCTS | Apr 23, 1981 | Substantially Equivalent | INSTRUMENTATION CAMERA, INC. |
| K810364 | DIGITAL RADIOGRAPHY SYSTEM | Mar 11, 1981 | Substantially Equivalent | ADAC LABORATORIES |
| K810189 | SIRECON COMPACT | Mar 02, 1981 | Substantially Equivalent | SIEMENS CORP. |
| K802953 | DIGITAL FLUOROGRAPHIC X-RAY SYSTEM | Jan 09, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K802150 | DIGITAL RADIOGRAPHY SYSTEM | Oct 23, 1980 | Substantially Equivalent | ADAC LABORATORIES |
| K801948 | DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM | Sep 26, 1980 | Substantially Equivalent | TECHNICARE CORP. |
| K801320 | SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 | Jul 21, 1980 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K801166 | PET-SCOPE II MODEL DIS-1611 | Jun 26, 1980 | Substantially Equivalent | DIAGNOSTIC INFORMATION, INC. |
| K800639 | ORBITOR | May 14, 1980 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K792225 | P1806 MOBILE C-ARM IMAGE INTENSIFIER | Dec 20, 1979 | Substantially Equivalent | PRECISE OPTICS |
| K791830 | L/U ARM - NEURO - VASCULAR #B5080B | Oct 26, 1979 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K781711 | EVALUSKOP | Oct 24, 1978 | Substantially Equivalent | SIEMENS CORP. |
| K771485 | PET-TV X-RAY IMAGE INTENSIFIER SYSTEM | Aug 16, 1977 | Substantially Equivalent | DIAGNOSTIC INFORMATION, INC. |
| K771298 | 6 L.L. SYSTEM | Aug 03, 1977 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K771096 | TELHTHERAPY SIMULATOR AECL-CP, G-3200 | Jul 01, 1977 | Substantially Equivalent | ATOMIC ENERGY OF CANADA |
| K770337 | FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. | Mar 01, 1977 | Substantially Equivalent | LITTON MEDICAL SYSTEMS |
| K770333 | FLUOROSCOPE, C-ARM | Mar 01, 1977 | Substantially Equivalent | LITTON MEDICAL SYSTEMS |
| K761285 | PET-SCOPE | Dec 29, 1976 | Substantially Equivalent | DIAGNOSTIC INFORMATION, INC. |
FEI Numbers
This FDA classification entry is associated with 139 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 139 registration numbers. Click on an entry to view related FDA registrations.