The following data is part of a premarket notification filed by Radlogics, Inc. with the FDA for Aimi-triage Cxr Ptx.
| Device ID | K193300 |
| 510k Number | K193300 |
| Device Name: | AIMI-Triage CXR PTX |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | RADLogics, Inc. 24 Westland Avenue, #28 Boston, MA 02115 |
| Contact | Moshe Becker |
| Correspondent | John J. Smith Hogan Lovells US LPP 555 13th 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 | 2019-11-27 |
| Decision Date | 2020-04-08 |