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FDA 510(k), K212616, Koios DS
FDA 510(k), K212616, Koios DS
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$149.00 USD
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510(K) Number: K212616
Device Name: Koios DS
Manufacturer: Koios Medical, Inc.
Device Classification Name: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Regulation Number: 892.2060
Classification Product Code: POK
Date Received: 08/18/2021
Decision Date: 12/16/2021
Regulation Medical Specialty: Radiology
Device Name: Koios DS
Manufacturer: Koios Medical, Inc.
Device Classification Name: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Regulation Number: 892.2060
Classification Product Code: POK
Date Received: 08/18/2021
Decision Date: 12/16/2021
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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