Identity
- Trade Name
- LG FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number. FDA UDI
- Model / Reference
- 17HK701G-WP FDA UDI
- Description
- Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number. FDA UDI
Identifiers
- Catalog Number
- 17HK701G-WP FDA UDI
- Primary DI / UDI-DI
- 00719192633148 FDA UDI
- 510(k) Number
- K183286 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
Yes
FDA UDI
Category: Indirect flat panel x-ray detector
Lg by Lg Electronics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Indirect flat panel x-ray detector.
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- DRX-1 Detector — CARESTREAM HEALTH, INC. · Class II
- P-75 — Konica Minolta, Inc. · Class II
- PEDRA — Radisen Co., Ltd. · Class II
- DX-D 60G — Agfa Corp. · Class II
Cleared under the same submission
K183286 also covers:
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
- Lg Electronics
Sources (1)
- FDA UDI 13284266-0505-4c85-93c0-37e33ddbf03b 35 fields · synced Jun 6, 2026