Identity
- Trade Name
- DRX - Ascend System FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, analogue FDA UDI
- Device Name
- DRX-ASCEND SYSTEM/QG-8000-3-R10-T600 FDA UDI
- Model / Reference
- DRX - Ascend System FDA UDI
- Description
- DRX-ASCEND SYSTEM/QG-8000-3-R10-T600 FDA UDI
Identifiers
- Catalog Number
- 1744309 FDA UDI
- Primary DI / UDI-DI
- 60889971744302 FDA UDI
- 510(k) Number
- K011486 FDA UDI
- FDA Product Code
- KPR FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, analogue 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
No
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: Stationary basic diagnostic x-ray system, digitalStationary basic diagnostic x-ray system, analogue
DRX - Ascend 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
K011486 also covers:
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — CARESTREAM HEALTH, INC.
- DRX - Ascend System — 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 77e1b6b3-6776-4dec-8268-ed12aaa544cf 35 fields · synced Jun 8, 2026