1
/
of
0
FDA 510(k), K190442, Koios DS for Breast
FDA 510(k), K190442, Koios DS for Breast
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K190442
Device Name: Koios DS for Breast
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: 02/25/2019
Decision Date: 07/03/2019
Regulation Medical Specialty: Radiology
Device Name: Koios DS for Breast
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: 02/25/2019
Decision Date: 07/03/2019
Regulation Medical Specialty: Radiology
Couldn't load pickup availability
- 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.
View full details