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FDA 510(k), K211678, Lunit INSIGHT MMG
FDA 510(k), K211678, Lunit INSIGHT MMG
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510(K) Number: K211678
Device Name: Lunit INSIGHT MMG
Manufacturer: Lunit Inc.
Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation Number:
Classification Product Code: QDQ
Date Received: 06/01/2021
Decision Date: 11/17/2021
Regulation Medical Specialty: Radiology
Device Name: Lunit INSIGHT MMG
Manufacturer: Lunit Inc.
Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation Number:
Classification Product Code: QDQ
Date Received: 06/01/2021
Decision Date: 11/17/2021
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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