Identity
- Trade Name
- 10HQ701G-B EUDAMED
- Device Name
- Flat Panel Digital X-ray Detector EUDAMEDFlat Panel Digital X-ray Detector EUDAMED
- Model / Reference
- 10HQ701G-BA EUDAMED10HQ701G-BP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806091932242 EUDAMED08806091878182 EUDAMED08806091932235 EUDAMED08806091876980 EUDAMED08806091876942 EUDAMED
- Basic UDI-DI
- 8806098DETECTORCK EUDAMED8806098DETECTOR-AWSW3 EUDAMED
- EMDN Code
- Z11030580 RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMED
- Market of Registration
- Germany EUDAMEDHungary EUDAMEDNorthern 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
10hq701g-B by LG Electronics Inc. — Class IIa — 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 | K221461 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8806098DETECTORCK | Class IIa | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- EUDAMED SRN
- KR-MF-000001897
- Authorised Representative
- LG Electronics Deutchland GmbH DE-AR-000044729
Sources (6)
- EUDAMED 9df86183-1f4c-487d-83e0-59b02346afe9 61 fields · synced Aug 4, 2026
- EUDAMED 02eb22ce-e0c2-46e0-a290-6a69970a3070 61 fields · synced May 11, 2026
- EUDAMED 6e6a57c8-5fd9-4884-a9d9-186aaedc8dd9 61 fields · synced May 16, 2026
- EUDAMED 35d23d89-7c10-4130-bda2-d4593f498207 61 fields · synced May 17, 2026
- EUDAMED d7e04c3f-b2a7-4b21-94de-48cd5d63d33e 61 fields · synced May 19, 2026
- FDA 510(k) K221461 1 fields · synced May 18, 2026