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 |