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
- [email protected]
- Phone
- 858 2487651
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2018-08-14 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2018-08-14 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2009-05-19 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2018-04-11 |
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2016-03-29 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 1992-11-19 |
| Breast Biopsy / Localization Tray | PXP | Class 1 | General, Plastic Surgery | No | 2022-09-09 |
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