Transpara

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

ScreenPoint Medical BV

The following data is part of a premarket notification filed by Screenpoint Medical Bv with the FDA for Transpara.

Pre-market Notification Details

• Device ID: K181704
• 510k Number: K181704
• Device Name: Transpara
• Classification: Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
• Applicant: ScreenPoint Medical BV Stationsplein 26 Nijmegen, NL 6512ab
• Contact: Nico Karssemeijer
• Correspondent: Nico Karssemeijer; ScreenPoint Medical BV Stationsplein 26 Nijmegen, NL 6512ab
• Product Code: QDQ
• CFR Regulation Number: 892.2090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-06-27
• Decision Date: 2018-11-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08719326450100	K181704	000