FDA Registration Active 🇳🇱 Netherlands

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reg #: 3042177665 · FEI: 3042177665 · Expires 2026
Products
7
Proprietary Names
760
Establishment Types
3
Classifications
7

Registration Details

Registration Name
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Registration Number
3042177665
FEI Number
3042177665
Status
Active
Expiry Year
2026
Initial Importer
No
Address
VEENPLUIS 6
City
BEST Noord-Brabant
Country
NL

Regulatory Submissions

510(k) Number
K181479

Owner / Operator

Firm Name
Philips Medical Systems International BV
Operator Number
1217116
Address
Veenpluis 6
City
Best
State
NL-NOTA
Postal Code
5684PC
Country
NL

US Agent

Business Name
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
Contact Name
Maria Heiling
Address
3721 Valley Centre Dr., Ste. 500
City
San Diego
State
CA
ZIP
92130
Country
US
Phone
858 2487651

Products

Device Name Product Code
Set, I.V. Fluid Transfer LHI
System, Nuclear Magnetic Resonance Imaging LNH
Coil, Magnetic Resonance, Specialty MOS
System, Nuclear Magnetic Resonance Spectroscopic LNI
System, Planning, Radiation Therapy Treatment MUJ
Guide, Needle, Surgical GDF
Breast Biopsy / Localization Tray PXP

Proprietary Names

Ingenia Ambition X Ingenia Ambition S Philips SENSE NV Coil 3T 8Ch SENSE NV Coil 3T/8ch Ingenia 3T CX R5.4 Ingenia 1.5T Ingenia 1.5T CX Ingenia 3T Ingenia 1.5T S MR 5300 Smart Fit TorsoCardiac 1.5T Siemens SYMPHONY SMALL EXTREMITY ARRAY dS Small Extremity 16Ch 1.5T Coil dS Small Extremity 16ch 3T dS Small Extremity 16Ch 3T Philips Array Coil Interface Box Toshiba 1.5T GP Flex Coil 528GE Series Synergy Shoulder Coil Philips MRCAT RTgo Airis Elite Rapid Extremity Coil Signa 1.5T 4Ch Shoulder Coil GE Signa 1.5T 4Ch Shoulder Coil Toshiba 1.5T 4Ch Shoulder Coil GE 1.5T 4Ch Shoulder Coil Phased Array Shoulder Coil Shoulder Array Coil GE 0.35T MFO PA WRIST Wrist Array Coil GE 1T SIGNA 4C PA WRIST (OEM) Lateral Array Coil Right VG STR VG BRST TABLE 1.5T 16CH GE450 FULSET GRD SENTINELLE BREAST MRI 8CH Tabletop 3T VS BRST 3T 4CH TT BIOPSY SET w PACKAGING Medial Plug VG STR Medial Single Loop Coil Left VG STR Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for GE 3T MRI System Model 4000451-51 Interface Box VG GE750 Lateral Single Loop Coil Left VGTT Medial Array Coil VG GE450 Lateral Single Loop Coil Right VG GE450 Medial Array Coil VGTT Single Loop Coil Right VT Lateral Array Coil Right VG GE450 Lateral Single Loop Coil Right VG GE750 Medial Plug VGTT Lateral Array Coil Left VGTT Lateral Single Loop Coil Left VG GE450 Cable Tray VG GE450 Medial Plug VG GE450 Lateral Array Coil Right VG GE750 Lateral Array Coil Right VGTT Lateral Array Coil Right VT Interface Box VT Lateral Single Loop Coil Left VG GE750 Interface Box VGTT 8Ch Lateral Single Loop Coil Right VGTT Lateral Array Coil Left VG GE450 Medial Array Coil VT Lateral Array Coil Left VT Lateral Array Coil Left VG GE750 Single Loop Coil Left VT Medial Array Coil VG GE750 Medial Plug VT Vanguard Breast MRI Table Medial Plug VG GE750 Medial Single Loop Coil Right VG STR SENTINELLE BREAST MRI 8CH Table for GE 3T VT1.5T 8CH TT TITAN FULL SET w GRID Medial Array Coil VS 8Ch SENTINELLE BREAST MRI 16CH Tabletop for GE 3T VS BRST 1.5T 8CH TT FUL SET w SHALOW RSR Sentinelle Breast MRI 8CH Tabletop for Siemens 1.5T Lateral Array Coil Right VS 8Ch Coil Medial Array VT 3T Vanguard Atlas/Titan VS BRST 3T 8CH TT FULL SET w ESPREE RSR VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR Lateral Single Loop Coil Right VG STR Coil Lateral 8CH Array Left VT 3T Lateral Single Loop Coil Left VG STR Medial Array Coil VG STR Sentinelle Breast MRI 8CH Tabletop 1.5T Lateral Array Coil Left VG STR Lateral Array Coil Right Vanguard Breast MRI Tabletop Coil Medial Array Coil VS Sentinelle Breast MRI 8CH Table for GE 1.5T SENTINELLE BREAST MRI 8CH Tabletop for SIEMENS 3T VS BRST 3T 8CH TT FULL SET w SHALLOW RSR Lateral Array Coil VS BRST 3T TT UPGRADE BIOPSY SET w PACKG VS BRST 3T 8CH TT FULL SET w TIM4G RSR SENTINELLE BREAST MRI 16CH Table for GE 1.5T Cable Tray HYP VG ST VS BRST 1.5T 8CH TT FULL SET w TIM4G RSR Lateral Array Coil Left VS 8Ch VG BREAST 1.5T 16CH GE450 FUL SET w GRID Lateral Array Coil Left VS BREAST 3T 8CH TT FULL SET w PACKAGING Ingenia 3T CX Ingenia Elition X Ingenia Elition S MR-RT CouchTop MRCAT Head & Neck/RTgo 5 RT couchTop XD SYN.BODY COIL 1.5T ODU 4598-005-5189x SENSE FLEX S COIL 1.5T ODU 4522-133-1719x T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x QUAD HEAD COIL 1.5T 4522-133-1727x SENSE FLEX L COIL 1.5T ODU 4522-133-1715x MRI COILS SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x SENSE SPINE COIL 1.5T ODU 4522-133-1724x SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x SENSE CARDIAC COIL 4522-133-1726x SENSE FLEX M COIL 1.5T ODU 4522-133-1717x SENSE SPINE COIL 1.5T 4522-133-1723x SHNC DRIVERBOX 1.5T 4598-000-5181x SHNC DRIVERBOX 1.5T ODU 4598-000-5182x Achieva 1.5T family Intera 1.5T family SENSE FLEX S COIL 1.5T 4522-133-1718x CIRC.COIL C3 1.5T 4598-000-5196x MICRO 23MM COIL 4598-000-5197x MICRO 47MM COIL 4598-000-5198x ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x CIRC.COIL C1 1.5T 4598-000-5184x SENSE CARDIAC COIL 4522-133-1725x SENSE FLEX M COIL 1.5T 4522-133-1716x SENSE FLEX L COIL 1.5T 4522-133-1714x Philips SENSE NV Coil, 1.5T 8Ch, Philips 1.5T Intera 16ch SENSE NV Array SENSE NV Coil 1.5T/8ch SENSE NV Coil 1.5T/16ch dS Knee Coil 8ch 1.5T dS Breast Coil 7ch 1.5T Philips 4-ch SENSE Wrist Coil 3T 4-ch SENSE Wrist Coil 1.5T INTERA 1.5T High Res Wrist Coil PA, Philips 4-ch SENSE Wrist Coil 1.5T OBC-250-PAN BREAST ARRAY COIL 0.6T Panorama 4Ch Breast Array ST SENSE Breast Coil dS FootAnkle 16 CH 1.5T dS HiRes Hand/Wrist 16Ch 1.5T dS FootAnkle 16 CH 3T dS Small Extremity 16CH 3T dS HiRes Hand/Wrist 16Ch 3T dS Small Extremity 16Ch 1.5T dS FootAnkle 16CH 3T dS FootAnkle 16CH 1.5T dS FootAnkle 16Ch 3T INTERA 1.5T Shoulder Coil Set 4Ch PA, Philips 4-ch SENSE Shoulder Coil 1.5T Ingenia Elition and MR 7700 MR Systems Altaire Rapid Head Coil Airis Elite Rapid Head Coil Ingenia Elition MR 7700 with Distributed Multi Nuclei Ingenia 3TCX 32 Ch Head dS Head 32ch 3T Achieva 1.5T, 3T, and Intera 1.5T Sense head coil 3T Sense NV Coil 3T OBC-300 Breast Array Coil Philips SENSE Wrist Coil 1.5T 8Ch GE Excite HD 1.5T 8 Channel Wrist (PRECISION EIGHT WRIST ARRAY) Siemens AVANTO/ESPREE 1.5T 8CH HRW ARRAY Siemens Symphony 1.5T 8Ch HRW Array GE Excite HDx PRECISION EIGHT WRIST ARRAY (8CH 1.5T) 8 Channel Wrist MR Coil Kit 1.5T Siemens TrioPrecision Eight Wrist Array (3T) GE, 3T 8CH WRIST COIL dS WRIST 8CH 3T GE 1.5T HDMR2-VALUE 8C WRIST Siemens TRIO/TIM 3T 8CH HRW ARRAY Philips dS 3T 8-ch Wrist Coil Philips dS 1.5T 8-ch Wrist Coil Siemens 1.5T 8Ch Avanto/Espree Precision Eight Wrist Array Philips SENSE Wrist Coil 3T 8Ch GE 1.5T 8CH WRIST COIL Siemens SYMPHONY 1.5T 8CH HRW ARRAY HRW-63-8 GE 3T SIGNA EXCITE 8C WRIST HRW-127-8 WRIST ARRAY COIL GE Excite HDx 3T Hi Res Wrist Array Coil PRECISION EIGHT WRIST ARRAY 8 Channel Wrist MR Coil Kit 3T dS Wrist 1.5T Symphony HR Wrist Array Coil 1.5T 8ch Wrist Array 8 Channel Wrist Coil HD 8Ch Wrist Array HD 8Ch WRIST ARRAY (Receive Only) 8 CHANNEL WRIST COIL 1.5T 8 CHANNEL WRIST COIL 3T dS Wrist 8CH 1.5T SENSE Wrist Coil 3T 8Ch SENSE Wrist Coil 1.5T 8Ch SIEMENS SYMPHONY HIGH RESOLUTION WRIST ARRAY Achieva, Intera,&Panaroma 1T R2 1.5T Musculoskeletal Array 1.5T Array Upper Extremity (MSK Coil) GE Excite HDx 1.5T 3Ch PHASED ARRAY UPPER EXTREMI GE Excite HD 1.5T 4 Channel Musculoskeletal Array Explorer gradients for Gyroscan Intera 1.5T MODELS EXL AND EXS EXTREMITY COIL SET Synergy Head/Neck Coil SmartPath to dStream for XR and 3T Upgrades dStream to R5.7 SmartPath to Ingenia Elition X Upgrades Achieva/Intera to R5.7 Evolution Upgrade 1.5T SmartPath to dStream for 1.5T Evolution Upgrade 3T PHILIPS 1.5T INTERA (BDAS) 6C KNEE ARRAY, Philips dS Knee 8ch 3T, Philips dS Knee 8ch 1.5T Philips 1.5TSENSE Intera High Res Knee Array Sense Knee Coil 1.5T SENSE Knee Coil 3T/8CH dS Knee Coil 1.5T/8ch SENSE Knee Coil 1.5T/8CH Toshiba 1.5T Knee SPEEDER, Philips SENSE Knee Coil 3T 8Ch, Phililps 6-ch SENSE Knee Coil 3T dS Wrist Coil 8ch 1.5T ds Wrist Coil 8ch 1.5T, Dlisting D551129 MRCAT Pelvis / RTgo 3 SENSE MSK S 8ch 1.5T Ingenia CX 3T Achieva R4 1.5T (Ingenia) Achieva R4 3T (ingenia) Ingenia CX 1.5T wBTS wPPU Sensor Accessories - 98980319363X wBTS Sensor Set, ECG 1 meter - 98980319364X wBTU PPU + RESP Module - 98980319445X wBTU VCG Module - 98980319444X MICROSCOPY COIL SET, INGENIA 3T dS MICROSCOPY 23MM COIL, INGENIA 3T dS MICROSCOPY 47MM COIL, INGENIA 3T dS MICROSCOPY 47MM COIL, INGENIA 1.5T MICROSCOPY COIL SET, INGENIA 1.5T dS MICROSCOPY 23MM COIL, INGENIA 1.5T HITACHI 1.5T 8C TORSO GE 0.7T OPENSPEED HFO 3C WRIST GE 0.7T OPENSPEED (HFO) WRIST MA Extremity Coil, Siemens 1.5T 8-CH HRK COIL dS HeadNeck 3T dS Head 3T dS Head 1.5T dS HeadNeck 1.5T dS Base 3T dS Base 1.5T Intera Family HAC-300 Head Array Coil Philips dS Small Extremity 8ch 3T Philips SENSE Small Extremity 3T 8CH Philips SENSE Small Extremity 1.5T 8Ch Philips dS Small Extremity 8ch 1.5T Extremity Coil 3T Sense Small Extremity 1.5T 8 Small extremity 8ch 3T Small extremity 8ch 1.5T dS SmallExtr 8ch 1.5T SENSE Small Extremity 3T 8 dS SmallExtr 8ch 3T GE 3T VHI 8C HEAD / BRAIN (OEM) GE Excite HDx 8 Channel High Res Head Array (1.5T) GE 3T HDMR2-VALUE 8C HEAD / BRAIN 8 CH HR Brain Array 3 T Brain Array 3T den HD 8Ch HiRes BRAIN array 8Ch High Resolution Brain Array Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems BlueSeal SE BlueSeal XE KFA-63 Knee and Foot Array Philips SENSE Breast Coil 1.5T 4-ch, Philips INTERA 1.5T Breast Coil 4Ch PA SENSE Breast Coil Upgrade to MR 7700 SmartPath to MR 7700 BlueSeal QE Upgrades dStream to R13 MR 7700 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Trolley Acoustic Hood HA Flex Trak HA FlexTrak II Tabletop Extender FlexTrak MR-OR 3T MR-OR 1.5T GE 1T HNC - OPENVIEW GE 1.5T HNC - OPENVIEW GE 1.5T HDMR2-VALUE 4C NVA COIL VALUE 1.5T GE COMPATIBLE HNC COIL SYS NEUROVASCULAR ARRAY COIL (Receive Only) 7 Channel Breast MR Coil Kit 3T, GE Exite HDx 3T 7CH BBC, Philips 7ch SENSE Breast Coil 3T Siemens 3T Biopsy Breast Coil (7CH) 7 CHANNEL BREAST COIL 3T TRIO BIOPSY BREAST ARRAY Sense Breast Coil 3T 7ch dS 1.5T 4CH Lateral Right dS 1.5T 4CH Lateral Left dS Headrest dS 1.5T 8CH Medial dS 1.5T Interface Box dS Patient Support dS 1.5T Medial Plug dS 1.5T 1CH Lateral Right dS 1.5T 1CH Lateral Left SENSE SPINE COIL, 1.5T 15-CH Toshiba 1.5T 2Ch Breast Coil 1.5T Breast Coil Assembly Intera Achieva Panorama 1T 8ch Wrist Coil Smart Fit Shoulder 1.5T 0.6T Marconi Wrist and Hand Array Philips ST SENSE Wrist Coil ST SENSE Wrist Coil Ingenia Elition R5.7.1 SP4 MR Systems Philips Sense Head / Neck 8 Philips Sense Head / Neck 16 SENSE Head 16 SENSE Spine 16 Philips Sense Spine 8 Philips Sense Torso 16 Philips Sense Torso 8 Philips Sense Spine 16 INgenia 1.5T CX and Ingenia 3T CX R5.3 GE 1.5T 8C HEAD / BRAIN COIL VALUE SENSE Head Coil 1.5T/8CH 1.5T HD 8HR Brain Array for HDe (Receive Only) HD 8Ch HiRes Brain Array (Receive Only) Philips 1.5T SENSE Intera 8 Ch Head Coil GE 1.5T HDMR2-VALUE 8C HEAD / BRAIN, MA Head Coil, GE 1.5T LXI 8C HEAD (OEM) 8Ch High Resolution Brain Array (Receive Only) 8 Channel High Resolution Brain Coil MR 5300 and MR 7700 R11 MR Systems Philips SENSE NV Coil 3T 16Ch SENSE NV Coil 3T/16ch GE 0.7T LARGE OPENSPEED GENERAL PURPOSE COIL, GE 0.7T SMALL OPENSPEED GENERAL PURPOSE COIL, GE 0.7T MEDIUM OPENSPEED GENERAL PURPOSE COIL, Ingenia Elition X R5.4 Quad Lower Extremity Coil (3T) GE, 1.5T HD, 8-Channel, Quad Extremity Coil Toshiba 1.5T 7Ch BBC 3T HD T/R Quad Extremity Coil (flat base) HD T/R QUAD EXTREMITY COIL 3T QUAD EXTREMITY COIL T/R GE, 3T HD, 8-Channel, Quad Lower Extremity Coil Philips INTERA 1.5T HNC 4Ch PA Quad Abdominal Flex Coil Toshiba 585 Series Phased Array coils. INgenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 Philips SENSE SPINE COIL 3T 15-ch, Philips SENSE SPINE COIL, 1.5T 15-CH SENSE Spine coil 1.5T 15-ch SENSE Spine Coil 3T 15-ch Achieva Family T/R HEAD COIL 3T 4598-001-5223x SENSE FLEX L COIL 3T ODU 4522-133-1722x SENSE FLEX M COIL 3T ODU 4522-133-1721x SENSE FLEX S COIL 3T ODU 4522-133-1720x Upgrades dStream to R12 SmartPath to dStream for 3T Panorama HFO Gyroscan Intera (7.5) Gyroscan Intera 3T INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly GEMS and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly PHC and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, HITACHI INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly Skyra, SHC Needle Sleeve 16G Sentinelle, Biopsy Grid 459801508642 Breast Grid (User-Sterilized) 989603209144 Lateral Grid dS Breast 16CH I/T Breast Grid (User-Sterilized) 989603203484 MRI Needle Block 18G Pillar Immobilization Plate Pillar Immobilization Plate LBS M-L Lateral Grid, Lower dS Breast 16CH I/T Lateral Grid, Upper dS Breast 16CH I/T Needle Sleeve 18G 989603203464 MRI Needle Block 12G 989603203584 Mammotome Immobilization Plate 989603209104 Pillar Immobilization Plate Fiducial Marker Grid Block Assembly Needle Sleeve 12G Fiducial Holder Needle Sleeve 14G 989603203594 OBC Grid Immobilization Plate 989603214204 Biospy Grid, Sterilized Pillar Immobilization Plate BBC Needle Block, 16G 989603209064 Grid Immobilization Plate LBS MRI Needle Block 8G Needle Block, 12G Pillar Immobilization Plate LBS C-C Fiducial Marker Sleeve Assembly Needle Block Holder MRI Needle Sleeve 12G Pillar Immobilization Plate BBC Grid Immobilization Plate LBS C-C Grid Plate, Enhanced Access Lateral Grid Immobilization Plate LBS M-L Medial Grid dS Breast 16CH 1/T 459801507722 Biospy Grid, Sterilized 989603203474MRI Needle Block 14G Grid Plate, Enhanced Access Medial 989603203574 Pillar Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly SMS and Clamp Stand 989603203524 Grid Immobilization Plate Needle Hub Assembly 989603204304 MRI Needle Block 16G INVIVO (FLORIDA, USA): DynaTRIM Complete, HITACHI DynaTRIM Grid Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, GEMS Biopsy Grid Needle Block, 14G INVIVO (FLORIDA, USA): DynaTRIM Complete, Skyra Baseplate assembly SHC and Clamp Stand Grid Immobilization Plate BBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, SMS Needle Block, 18G Lateral Grid dS Breast 16CH 1/T INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, PHC INVIVO (FLORIDA, USA): DynaTRIM Clamp stand assembly INVIVO (FLORIDA, USA): DynaTRIM Complete, GEMS DynaTRIM GE 1T Signa 4CH OBC GE Excite HDe 1.5T 4CH (HDMR2-VALUE 4C OBC) GE 1.5T SIGNA 4C PA OBC GE Excite HD 1.5T 4 Channel Breast Coil Breast Array Coil BREAST ARRAY COIL (Receive Only) dS Flex Coil L (3T) dS Anterior Coil (3T) dS Anterior Coil (1.5T) dS Flex Coil S (3T), dS Flex Coil M (1.5T), dS Flex Coil M (3T), dS Flex Coil L (1.5T) dS Head-Neck Coil (3T), dS Head Coil (1.5T), dS Head Coil (3T), dS Flex Coil S (1.5T) FRU, COIL ASSY, PHC 1.5T 16CH 1.5T AND 3T GENERAL PURPOSE FLEX COILS dS FLEX-L 1.5T dS FLEX-M 3T dS FLEX-M 1.5T dS FLEX-L 3T dS Anterior 1.5T dS FLEX-S dS Anterior Coil (3T), dS Base Coil (1.5T), dS Base Coil (3T), dS Head-Neck Coil (1.5T) dS Anterior 3T dS FLEX-S 1.5T dS Flex Coil S (1.5T) GE 1.5T Excite HDx 1.5T KFC DS (Quadrature Lower Extremity Coil) QUADRATURE KNEE / FOOT COIL 1.5T HD T/R QUAD EXTREMITY COIL (flat base) Quardrature Knee/Foot Coil 1.5T QUAD EXTREMITY COIL T/R GE 1.5T Quadrature Lower Extremity Coil (KFC DS) Siemens 3T 8-CHANNEL HRH COIL (High Res Head Array), 8 Channel Head Array GE 0.5T SP Tx/Rx INTERVENTIONAL SPINE ARRAY Philips SENSE Head Coil, 8Ch 3T, SENSE Head Coil, 6Ch 3T ST SENSE Breast Dx Coil Kit, Enhanced Access, Bilateral Upgrade Breast 7 Biopsy Pack, 1.5T Philips 4-ch SENSE NeuroVascular Coil 3T 3T SENSE MEDIUM GP FLEX 8 dS FootAnkle Coil 8ch 1.5T GE Signa Excite III Brain Coil Philips dS Head 32ch 3T GE Signa Excite II Brain Coil Philips SENSE Intera Achieva 3T Brain Coil GE Signa Excite I Brain Coil SENSE Head Coil 3T 32 1.5T/3T 8 ch medium general purpose Flex Coil SENSE MASK M 8Ch 1.5T Siemens 1.5T ESPREE 8Ch FAC Siemens 1.5T Symphony 8Ch FAC GE Excite 3T HDx 8Ch FAC Siemens 3T Tim/Trio 8Ch FAC (Foot/Ankle Coil) GE Excite HDx 1.5T HDx 8Ch 1.5T FAC Siemens 8 Channel Foot Ankle MR Coil Kit Verio 3T GE HD 1.5T 8C Foot and Ankle SMS 1.5T Espree 8Ch FAC (Foot/Ankle Coil) Siemens Avanto 1.5T 8Ch FAC (Foot/Ankle Coil) Siemens 3T TIM/TRIO 8Ch FAC Philips dS 1.5T 8-ch Foot Ankle Coil Philips SENSE Foot-Ankle Coil 1.5T 8ch Siemens 1.5T AVANTO 8Ch FAC Philips SENSE Foot-Ankle Coil 3T 8ch GE Excite 1.5T 8Ch Foot and Ankle Coil (FAC) GE HD 3T 8C Foot and Ankle Philips dS 3T 8-ch Foot Ankle Coil 8 Channel Foot Ankle MR Coil Kit 3T 8 Channel Foot Ankle MR Coil Kit 1.5T dS FOOTANKLE 8CH 1.5T HD 8Ch Foot Ankle Coil HD 8CH Foot Ankle Coil (Receive Only) dS FootAnkle 8Ch 3T dS Foot-Ankle Coil 8ch 3T SIEMENS 8 CHANNEL FOOT AND ANKLE ARRAY SENSE Foot-Ankle Coil 8CH FOOT ANKLE MR COIL 3T 8 CHANNEL FOOT ANKLE COIL 1.5T Ingenia Ingneia CX Ingenia Ambition Siemens 1.5T HIGH-RESOLUTION SHOULDER ARRAY Philips dS 3T MIRA 8C SENSE SHOULDER- Philips GE 3T Signa Excite 8CH Shoulder Philips SENSE Shoulder Coil 3T Siemens 1.5T VISION SHOULDER [DIR] Philips dS Shoulder 8ch 1.5T Siemens 3T 8CH SHOULDER Siemens 3T Precision Shoulder Array (8Ch) Philips SENSE Shoulder Coil 1.5T Siemens 1.5T Precision Shoulder Array GE 1.5T Signa Excite 8CH Shoulder 1.5T 8CH Obelix digital shoulder coil SENSE Shoulder Coil 3T 1.5T Precision Shoulder Array 3T Precision Shoulder Array dS Shoulder 8ch 1.5T dS Shoulder 8ch 3T SENSE Shoulder Coil 1.5T Philips dS Breast 7ch 1.5T Toshiba 1.5T 7CH BBC GE Excite 1.5T 7CH BBC Philips dS Breast 7ch 3T Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate, GE LBS 3T 16CH MammoTrak Interventional Breast Coil 1.5T Philip Interventional Coil 3T, PHC, Achieva TX Siemens Luminescence 1.5T Breast Coil 7 Ch Coil/ASM/Breast Coil for Echelon LBS 3T SMS 7 ch GE LBS 1.5T16CH GE Excite HDx 1.5T HDx 7CH BBC Siemens 1.5T Symphony 7Ch BBC (Breast Biopsy Coil) Siemens Luminescence 1.5T Breast Coil 16 Ch HITACHI 1.5T 7C BREAST GE HDx 3T 7Ch Biopsy Breast GE LBS 3T 7CH Biopsy Breast Coil Grid Immobilization Plate LBS, Pillar Immobilization Plate LBS, Needle Block Holder, GE Excite HDx 1.5T 7ch BBC Siemens AVANTO 1.5T BBC Siemens Luminescence 3T Breast Coil 16 Ch Philips 7ch SENSE Breast Coil 1.5T GE Excite 1.5T 7Ch Biopsy Breast Array dS Breast 16ch 1.5T dS Breast 7ch 3T dS Breast 7ch 1.5T SENSE Breast Coil 7ch BREAST SPEEDER AVANTO BIOPSY BREAST ARRAY Fiducial Holder, Needle Hub Assembly, Siemens SYMPHONY 1.5T BBC Mammotrak Interventional Coil 1.5T Achieva TX Interventional Coil 3T PHILIPS 1.5T INTERA ACHIEVA (CDAS) BBC 4Ch Right Lateral Coil Sen 1.5T PATIENT SUPPORT BREAST SEN Medial Array Coil VS 16Ch Sentinelle Breast MRI Tabletop with 16 Channel Coil Array For Siemens 1.5/3T MRI Systems Single Loop Coil Left VS Interface Box VS 16Ch 1Ch Left Coil Element Sen 3T Lateral Array Coil Left VS 16Ch 1Ch Right Coil Element Sen 1.5T 16Ch Interface Box Breast Coil Sen 3T 4Ch Left Lateral Coil Sen 1.5T Single Loop Coil Right VS Medial Plug Sen 3T 16Ch Interface Box Breast Coil Sen 1.5T Medial Plug Sen 1.5T 1Ch Right Coil Element Sen 3T 1Ch Left Coil Element Sen 1.5T Lateral Array Coil Right VS 16Ch 8Ch Medial Coil Sen 3T Medial Plug VS 4Ch Left Lateral Coil Sen 3T 4Ch Right Lateral Coil Sen 3T 8Ch Medial Coil Sen 1.5T SENTINELLE BREAST MRI 16CH Tabletop for Siemens 1.5T Vanguard for Siemens Breast MRI Auxillary Table SENTINELLE BREAST MRI 16CH Tabletop for Siemens 3T SENTINELLE BREAST MRI 8CH Tabletop for Siemens 1.5T 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil Gyroscan Intera Intera Sensation Family QSC-085 Shoulder Array Coil dS FootAnkle 16 Ch 1.5T Coil dS FootAnkle 16Ch 1.5T dS Shoulder 16Ch 3T 3T 16Ch GE Shoulder Coil 1.5T 16Ch GE Shoulder Coil dS 1.5T 16CH SHOULDER, COIL dS 3T 16CH SHOULDER, COIL 16Ch Shoulder Coil dS Shoulder 16Ch 1.5T BREAST ARRAY COIL, Philips 4-ch SENSE Breast Coil 3T 4-ch SENSE Breast Coil 3T GE Excite HD 1.5T 4 Channel Wrist Coil (HRW-GE SIGNA) MA Wrist Coil GE 1.5T HDMR2-VALUE 4C WRIST COIL HD 4CH Wrist Array (Receive Only) HIGH RESOLUTION WRIST COIL(Receive Only) GE 1.5T 4C PA WRIST (OEM) Intera I/T MR system Shoulder Array MR Coil kit VERIO, Siemens 3T VERIO, QSC, Siemens QSC SET, TRIO/TIM 3T 4CH SHOULDER ARRAY COIL SET 4 CH Shoulder Large - 4 CH Shoulder Small SHOULDER ARRAY SMALL SHOULDER ARRAY LARGE Siemens 3T 8-CHANNEL HRH COIL (High Res Head Array) Accessories, SENSE Head Coil, 6Ch 3T Philips SENSE Head Coil, 8Ch 3T SENSE Head Coil 3T/8CH SENSE Head Coil, 6Ch 3T 8 Channel Head Array GE 1.5T HDMR2-VALUE 8C NVA, MA Neurovascular Coil, GE 1.5T SIGNA EXCITE 8C NVA COIL (OEM), GE Excite HD 1.5T 8-CHANNEL NVA COIL GE Excite HDx 1.5T 8 Channel Neurovascular Array 8Ch Neuro Vasculat Array (Receive Only) HD 8Ch NV ARRAY GE 16-CH 1.5T Hand/Wrist Coil Avanto/Espree 1.5T 8Ch High Resolution Knee Array GE EXCITE 1.5T SIGNA HD 8C Tx/Rx KNEE (OEM) GE EXCITE 1.5T 8 CHANNEL T/R , High Res Knee Array Coil (HRK) 8 Channel Knee Array MR Coil Kit Avanto, Siemens HRK, AVANTO 1.5T 8CH PA 1.5T HD T/R KNEE ARRAY 1.5T HD T/R Knee Coil (flat base) HIGH RESOLUTION T/R KNEE COIL 8CH HIGH RESOLUTION KNEE ARRAY 3T HD T/R KNEE ARRAY 16 Breast Coil GE 3T 32 Channel Cardiac Coil (Anterior Only) GE 1.5T 32 Channel Cardiac Coil- Anterior Only SMS 1.5T 32 Channel Cardiac Coil GE 3T 32 Channel Cardiac Coil PHILIPS 3T INTERA ACHIEVA 32C CARDIOVASCULAR Siemens 1.5T AVANTO 32C CARDIOVASCULAR GE 3T 32 Channel Cardiac Coil (Posterior) Siemens 1.5T 32 CHANNEL CARDIAC Siemens 3T TRIO A TIM 32C CARDIOVASCULAR GE 3T 32 Channel Cardiac Coil- Anterior Only Siemens 3T 32 CH BAC Philips SENSE Torso/Cardiac Coil 1.5T GE 1.5T 32 Channel Cardiac Coil (Anterior) GE 3T 32 Channel Cardiac Coil- Anterior and Posterior GE Cardiac Coil, 1.5T, 16ch GE 3T 32 Channel Cardiac Coil (Anterior) GE 1.5T 32 Channel Cardiac Coil SMS 3T 32 Channel Cardiac Coil GE 1.5T 32 Channel Cardiac Coil (Posterior) 3T 32Ch Cardiac Coil - Anterior 1.5T 32Ch Cardiac Coil- Anterior 1.5T 32CH Cardiac Coil- Anterior SENSE Torso/Cardiac Anterior Coil 3T 32Ch CardiaC Coil- Anterior 16 Ch Body Array Anterior 3T SENSE Torso/Cardiac Posterior Coil 16 Ch Body Array Anterior 1.5T 3T 32Ch Cardiac Coil- Posterior 1.5T 16CH Cardiac Coil- Anterior 1.5T 16CH Cardiac Coil- Posterior 4ch SENSE Shoulder Coil 3T 4ch SENSE Shoulder Coil 1.5T 4-ch SENSE Shoulder Coil 3T Siemens Symphony Shoulder Coil GE Excite HD 1.5T 4 Channel Shoulder Coil Siemens AVANTO SHOULDER ARRAY COIL SET GE 1.5T SIGNA 4C PA SHOULDER Expert Shoulder Array Baseplate Hitachi 1.5T Echelong PA Shoulder Siemens 1.5T AVANTO QUAD SHOULDER COIL S Siemens ESPREE SHOULDER ARRAY COIL SET Siemens 1.5T ESPREE QUAD SHOULDER COIL S Siemens AVANTO SHOULDER COIL BASEPLATE UPGRADE Large Shoulder Array Coil (Receive Only) Shoulder Array Coil Small Shoulder Array Coil Large Shoulder Array Coil Set Siemens Verio 3T Brain Coil GE 16 Ch Knee Coil 3T Siemens 1.5T 16 Channel Knee Coil Philips SENSE Knee Coil 16Ch 3T Siemens Trio 3T Brain Coil Philips dS Knee 16ch 1.5T GE 16 Ch Knee Coil 1.5T Philips SENSE Knee Coil 16Ch 1.5T Siemens 3T 16 Channel Knee Coil Philips dS T/R Knee 16ch 3T dS Knee 16 ch 1.5T dS SMALL EXTREMITY 16CH 1.5T Sense Knee 8ch 3T dS Knee Coil 16ch 1.5T SENSE Knee Coil 16CH TX dS T/R Knee 16ch 3T SENSE Knee Coil 16CH Siemens HRK, TRIO/TIM 3T 8CH Siemens 3T 8Ch High Resolution Knee Array GE 3T HD Tx/Rx 8C KNEE GE, 1.5T 8CH T/R Knee COIL GE Excite 3T HDx Tx Rx KNEE COIL GE, 3T 8CH T/R Knee COIL 8 CHANNEL KNEE COIL Siemens Trio 3T 8 Channel T/R HRK (High Res Knee) 3T HD T/R Knee Coil (flat base) 8 Ch High Resolution Knee Array dS Breast 16CH 1.5T Philips 1.5T Intera 16ch SENSE NV Array Grid dS Breast 16CH I/T dS Breast 16 CH I/T 1.5T; dS Breast 16 CH I/T 3T Philips SENSE NV Coil, 1.5T 8Ch Sense NV 16 channels Philips dS Breast 16ch 1.5T Philips dS Breast 16ch 3T dS Breast 16CH 3T I/T dS Breast Adaptive 16CH 3T dS Breast Adaptive 16CH 1.5T GE 0.35T MFO 4C PA OBC Vanguard MRI Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems Medial Coil Element Sen 1.5T 3Ch Left Coil Element Sen 1.5T Interface Box Breast Coil Sen 3T Medial Coil Element Sen 3T Interface Box Breast Coil Sen 1.5T Cable Tray HYP VG STR 3Ch Right Coil Element Sen 1.5T Interface Box VS 8Ch 3Ch Right Coil Element Sen 3T 3Ch Left Coil Element Sen 3T Breast MRI 8ch Table for GE 1.5T 1.5T Breast Speeder 8ch Breast MRI 8ch Tabletop for Siemens 1.5T Panorama 0.23T 4Ch OBC Mammotrak Diagnostic Coil 3T Philips MammoTrak Interventional Breast Coil, 3T, 7CH Siemens 16 CH Breast 3T (LBS) MammoTrak Interventional Breast Coil 3T MammoTrak Diagnostic Breast Coil 1.5T Mammotrak Diagnostic Coil 1.5T Mammotrak Interventional Coil 3T dS Breast 16ch 3T Philips MammoTrak Interventional Breast Coil, 3T, 16CH Philips 3T SENSE GP Flex 8 1.5T SENSE GP Flex 8 SENSE XL Torso Coil Sentinelle Endo Coil Array for Pelvic Imaging dS 3T Medial Plug dS 3T 8CH Medial dS 3T 1CH Lateral Left dS 3T 4CH Lateral Left dS 3T 4CH Lateral Right dS 3T 1CH Lateral Right dS 3T Interface Box Ingenia 1.5T S - 781-347 Ingenia 1.5T - 781-341 MRCAT Brain / RTgo 4

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device