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FDA 510(k), K183285, cmTriage
FDA 510(k), K183285, cmTriage
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510(K) Number: K183285
Device Name: cmTriage
Manufacturer: CureMetrix, Inc
Device Classification Name: radiological computer-assisted prioritization software for lesions
Regulation Number: 892.2080
Classification Product Code: QFM
Date Received: 11/26/2018
Decision Date: 03/08/2019
Regulation Medical Specialty: Radiology
Device Name: cmTriage
Manufacturer: CureMetrix, Inc
Device Classification Name: radiological computer-assisted prioritization software for lesions
Regulation Number: 892.2080
Classification Product Code: QFM
Date Received: 11/26/2018
Decision Date: 03/08/2019
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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