FDA Registration
Active
🇮🇳 India
WIPRO GE HEALTHCARE PRIVATE LTD
Reg #: 9613936
·
FEI: 1000571342
·
Expires 2026
Products
5
Proprietary Names
140
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- WIPRO GE HEALTHCARE PRIVATE LTD
- Registration Number
- 9613936
- FEI Number
- 1000571342
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK
- City
- WHITEFIELD, BANGALORE Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K143251
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2015-02-11 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2011-11-03 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2011-11-03 |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2004-09-24 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2014-09-18 |
Proprietary Names
SIGNA Explorer
SIGNA Creator
SIGNA Explorer Quantum
SIGNA MR355
SIGNA MR360
Optima MR450w GEM XP Gradient
Optima MR450w GEM
Optima MR450w
1.5T 8Ch GEM Breast Coil
liberty 9000 8-ch breast coil with disposable biopsy plate
1.5T HD Breast Array
Lateral Large Grid Biopsy Plate
Medial Large Grid Breast Biopsy Plate
1.5T HD Flat GEM Table Breast Array
Discovery MR750 3T
DISCOVERY MR 750- 3T SPLIT HEAD COIL
Discovery MR750 System
GP Flex Coil 1T.
GP Flex Coil 1.5T
Discovery MR750w 3T
Discovery MR750W
MR 750W
3T GEM PA (Aurora only)
3T GEM HNU (Aurora only)
3T GEM PVA (Aurora only)
3T GEM Anterior Array (Aurora only)
1.5T SPLIT HEAD COIL
3T SPLIT HEAD COIL
3T GE Signa Excite HD MR System
1.5T GE Signa Excite HD MR System
1.5T Signa HD
premier 9000 8 channel phased array
1.5T, 8Ch CTL coil-HDx
CTL
8 Channel CTL Coil
Signa HD 1.5T 8-Ch CTL Coil
1.5T HD 8 CH CTL Coil
1.5T 8 CH CTL Coil
Signa Excite 1.5T Expert.
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
5" ROUND COIL 1.5T
3" ROUND COIL 1.5T
3T SIGNA HDxt Mobile
SIGNA VIBRANT
3T SIGNA HDXt
1.5T SIGNA HDXt
1.5T Signa HDxt Mobile
1.5T 4CH Large Flex Coil
1.5T 4CH Small Flex Coil
9E Express AA coil
16CH Express HNA coil
8ch Express PA coil
1.5T EXPRESS COIL - 16E HEAD NECK ARRAY
1.5T EXPRESS COIL - 9E ANTERIOR ARRAY
DISCOVERY MR 450-1.5T SPLIT HEAD COIL
Discovery MR450
3T HD Breast Array
3T 8Ch GEM Breast Coil
3T HD FLAT GEM Table Breast Array
GE 1.5T SIGNA HDE MR SYSTEM
8ch Express Suite
Optima MR360
Brivo MR355
EXPRESS COIL - HEAD NECK ARRAY
EXPRESS COIL - ANTERIOR ARRAY
EXPRESS COIL - POSTERIOR ARRAY
1.5T, 4 CH. CTL SPINE COIL,
Premier 7000 CTL Spine coil
Signa HD 1.5T CTL Spine Coil
PHASED ARRAY-HDe
1.5T 4 Ch. Premier 7000 CTL Coil
Signa HDe 1.5T 4CH CTL Spine Coil
Signa HDi 1.5T
GE 3T Signa HDxt MR System
Signa HDi
GE 1.5T Signa HDx MR System
GE 1.5T Signa HDxt MR System
GE 3T Signa HDx MR System
Signa Vibrant
Jedi
TTH
Jedi80RF1T
Jedi80R1T
Jedi 80 RD 1T
Jedi42CT
Jedi 50 Plus R1T
ZEUS
Zyx
Jedi 80 RF 1T
Jedi50R1T
JEDI 80 RF1T
Jedi 50 R 1T
Jedi NP+V1.5
TTH MAESTRO
TTH HAWKEYE
DMR
JEDI 60 DC
Jedi 60 DC
Djinn Mammo
Jedi80RF2T
Prisme
Jedi 42 CT
JEDI SC FAST kV
DJINN BEETLE
VMX
MPPU
JEDI HP
JEDI 100 VASC 1T
CT MINI
Jedi60CT
X-Ray Generator
ZJ/QJ
Prodigy/DPX Series High Voltage Power Supply
Jedi 60 DC LITE
SYJ
MPG50
JEDI 60 DC LITE
Jedi 60DC Lite
MPG100
VAMP
Jedi 80 RF 2T
JEDI VCT
Jedi 80 R 1T
TTH 8800
ZEUS, ZJ/QJ
Jedi 100 VASC 1
BONZAI
Djinn Beetle
Jedi 60 CT
Jedi 60DC
GAIA INTERVENTIONAL GENERATOR
Djinn Tonix
1.5T Split Head Coil
Optima MR 450w GEM
Optima MR450w 1.5T
Discovery MR450 1.5T
Optima MR 450w
Discovery IQ
Discovery IQ Clarity
GE 3T General Purpose Flex Coil
Establishment Types
Manufacture Medical Device