FDA 510(k), K202546, LVivo Seamless
FDA 510(k), K202546, LVivo Seamless
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510(K) Number: K202546
Device Name: LVivo Seamless
Manufacturer: DiA Imaging Analysis Ltd
Device Classification Name: Automated Radiological Image Processing Software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 09/02/2020
Decision Date: 09/29/2020
Regulation Medical Specialty: Radiology
125 pages (134 of 259 pages fully redacted)