FDA 510(k), K193229, Transpara

FDA 510(k), K193229, Transpara

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510(K) Number: K193229
Device Name: Transpara
Manufacturer: Umar Waqas
Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation Number: QDQ
Classification Product Code: 11/22/2019
Date Received: 03/05/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

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