The following data is part of a premarket notification filed by Lunit Inc. with the FDA for Lunit Insight Cxr Triage.
| Device ID | K211733 |
| 510k Number | K211733 |
| Device Name: | Lunit INSIGHT CXR Triage |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Lunit Inc. 15th Floor, 27 Teheran-ro 2-gil Seoul, KR 06241 |
| Contact | Seulhee Jung |
| Correspondent | Colin S. Jacob Hogan Lovells Columbia Square 555 Thirteenth Street, Northwest Washington, DC 20004 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-04 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800076000124 | K211733 | 000 |
| 08800076000179 | K211733 | 000 |