FDA Registration
Active
🇺🇸 United States
DR-FIT X-ray System
Reg #: 1317307
·
FEI: 1317307
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Carestream Health, Inc
- Registration Number
- 1317307
- FEI Number
- 1317307
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1049 West Ridge Road
- City
- Rochester
- State
- NY
- ZIP
- 14615
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201373
Owner / Operator
- Firm Name
- Carestream Health, Inc.
- Operator Number
- 9097221
- Address
- 150 Verona Street
- City
- Rochester
- State
- NY
- Postal Code
- 14608
- Country
- US
- Correspondent
- Alyssa J Haig
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2020-07-09 |
Proprietary Names
DR-FIT X-ray System
DRX-Compass X-ray System
Establishment Types
Manufacture Medical Device