The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 14hq901g-b.
| Device ID | K214044 |
| 510k Number | K214044 |
| Device Name: | 14HQ901G-B |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | LG Electronics Inc. 77, Sanho-daero Gumi-si, KR 39381 |
| Contact | Jinhwan Jun |
| Correspondent | Dogyun Im GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, KR 03909 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195174039663 | K214044 | 000 |