Identity
- Trade Name
- 14HQ901G-B EUDAMED
- Device Name
- Flat Panel Digital X-ray Detector EUDAMED
- Model / Reference
- 14HQ901G-BP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806091487643 EUDAMED
- Basic UDI-DI
- 8806098DETECTOR-AWSW3 EUDAMED
- EMDN Code
- Z11030580 RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
14hq901g-B by LG Electronics Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214044 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8806098DETECTOR-AWSW3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- EUDAMED SRN
- KR-MF-000001897
- FDA Applicant
- Lg Electronics.Inc
- Authorised Representative
- LG Electronics Deutchland GmbH DE-AR-000044729
Sources (2)
- EUDAMED d7893d56-a8a0-422a-8ee0-4287755e5483 85 fields · synced Jun 18, 2026
- FDA 510(k) K214044 1 fields · synced May 18, 2026