The following data is part of a premarket notification filed by Curemetrix, Inc with the FDA for Cmtriage.
| Device ID | K183285 |
| 510k Number | K183285 |
| Device Name: | CmTriage |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | CureMetrix, Inc 9404 Genesee Ave., Suite 330 La Jolla, CA 92037 |
| Contact | Kevin Harris |
| Correspondent | Kevin Harris CureMetrix, Inc 9404 Genesee Ave., Suite 330 La Jolla, CA 92037 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-26 |
| Decision Date | 2019-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006442668 | K183285 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CMTRIAGE 90147689 not registered Live/Pending |
CureMetrix, Inc. 2020-08-30 |
![]() CMTRIAGE 87678709 not registered Live/Pending |
CureMetrix, Inc. 2017-11-09 |