The following data is part of a premarket notification filed by Lunit Inc. with the FDA for Lunit Insight Mmg.
| Device ID | K211678 |
| 510k Number | K211678 |
| Device Name: | Lunit INSIGHT MMG |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | Lunit Inc. 15 Floor, 27 Teheran-ro-2-gil, Gangnam-gu, Seoul, KR 06241 |
| Contact | Joohee Lee |
| Correspondent | John Smith Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800076000056 | K211678 | 000 |