Identity
- Trade Name
- CARESTREAM DRX-1 System FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- CARESTREAM DRX-1 SYSTEM FDA UDI
- Model / Reference
- CARESTREAM DRX-1 System FDA UDI
- Description
- CARESTREAM DRX-1 SYSTEM FDA UDI
Identifiers
- Catalog Number
- 8622797 FDA UDI
- Primary DI / UDI-DI
- 60889978622795 FDA UDI
- 510(k) Number
- K090318 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Indirect flat panel x-ray detector
CARESTREAM DRX-1 System by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090318 also covers:
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System Detector — CARESTREAM HEALTH, INC.
- DRX Plus 4343 DETECTOR — CARESTREAM HEALTH, INC.
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- DRX-Transportable System — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- TDR 3543 Detector — CARESTREAM HEALTH, INC.
- TDR 3543C Detector — CARESTREAM HEALTH, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI 449e7a38-5588-4ed2-9ce0-fe231fe20e29 35 fields · synced Jun 8, 2026