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FDA 510(k), K183182, Critical Care Suite
FDA 510(k), K183182, Critical Care Suite
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510(K) Number: K183182
Device Name: Critical Care Suite
Manufacturer: Camille Vidal
Device Classification Name: Radiological Computer-Assisted Prioritization Software For Lesions
Regulation Number: QFM
Classification Product Code: 11/19/2018
Date Received: 08/12/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Critical Care Suite
Manufacturer: Camille Vidal
Device Classification Name: Radiological Computer-Assisted Prioritization Software For Lesions
Regulation Number: QFM
Classification Product Code: 11/19/2018
Date Received: 08/12/2019
Decision Date: Substantially Equivalent (SESE)
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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