FDA Registration
Active
🇺🇸 United States
GE HEALTHCARE
Reg #: 3004526608
·
FEI: 3004526608
·
Expires 2026
Products
7
Proprietary Names
36
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- GE HEALTHCARE
- Registration Number
- 3004526608
- FEI Number
- 3004526608
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 500 W. Monroe Street
- City
- Chicago
- State
- IL
- ZIP
- 60661
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061372
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2000-03-06 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2025-04-15 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2012-11-21 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2012-11-21 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2023-12-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2012-11-21 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-01-17 |
Proprietary Names
Centricity AW Suite
MR Contour DL
Centricity Perinatal
Digital Expert Access with Remote Scanning
Centricity Radiology RA600, Centricity Cardiology CA 1000, and Digital Hardcopy
Centricity Radiology RA600 / Centricity Cardiology CA1000 / DHC
Centricity PACS IW
Centricity Universal Viewer
Centricity Cardio Imaging
View
Centricity PACS
Centricity PACS (RA1000)
Centricity PACS (RA1000) 4.x
Centricity PACS (RA1000) 6.x
Centricity PACS 6.x
Centricity PACS 4.x
Centricity PACS (RA1000)7.x
Centricity PACS 7.x
Centricity Universal Viewer 6.x
Centricity Universal Viewer 7.x
Centricity Universal Viewer Zero Footprint client
Centricity Universal Viewer Zero Footprint
PACS-IW with Universal Viewer
Universal Viewer
Universal Viewer 8
CRC
Customer Remote Console
Remote Console
Digital Expert Access
Centricity PACS Web Diagnostic
Centricity Cardiology CA1000 v1
Centricity Radiology R600 v7
DHC
CareIntellect Perinatal
Mural Perinatal Surveillance
Mural Clinical Viewer
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility