The following data is part of a premarket notification filed by Aidoc Medical, Ltd. with the FDA for Briefcase, Rib Fractures Triage (ribfx).
| Device ID | K202992 |
| 510k Number | K202992 |
| Device Name: | BriefCase, RIB Fractures Triage (RibFx) |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Aidoc Medical, Ltd. 3 Aminaday St. Tel-aviv, IL 6706703 |
| Contact | Nimrod Epstein |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street NW 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 | 2020-09-30 |
| Decision Date | 2021-04-14 |