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FDA 510(k), K181704, Transpara
FDA 510(k), K181704, Transpara
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510(K) Number: K181704
Device Name: Transpara
Manufacturer: Nico Karssemeijer
Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation Number: QDQ
Classification Product Code: 06/27/2018
Date Received: 11/21/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Transpara
Manufacturer: Nico Karssemeijer
Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation Number: QDQ
Classification Product Code: 06/27/2018
Date Received: 11/21/2018
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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