Transpara

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

Screenpoint Medical B.V.

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

Pre-market Notification Details

• Device ID: K192287
• 510k Number: K192287
• Device Name: Transpara
• Classification: Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
• Applicant: Screenpoint Medical B.V. Mercator II, 7th Floor, Toernooiveld 300 Nijmegen, NL 6525ec
• Contact: Umar Waqas
• Correspondent: Umar Waqas; Screenpoint Medical B.V. Mercator II, 7th Floor, Toernooiveld 300 Nijmegen, NL 6525ec
• Product Code: QDQ
• CFR Regulation Number: 892.2090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-22
• Decision Date: 2019-12-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08719326450124	K192287	000