The following data is part of a premarket notification filed by Medcognetics, Inc. with the FDA for Cognet Qmtriage.
| Device ID | K220080 |
| 510k Number | K220080 |
| Device Name: | CogNet QmTRIAGE |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | MedCognetics, Inc. 17217 Waterview Parkway Suite 1.202E Dallas, TX 75252 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford MedCognetics, Inc. 17217 Waterview Parkway Suite 1.202E Dallas, TX 75252 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007434709 | K220080 | 000 |