ClearanceBrief
Company ยท NL

Screenpoint Medical B.V.

FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer7
QIHAutomated Radiological Image Processing Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 14, 2026K260898Transpara (2.1.0)
Screenpoint Medical B.V., NL
QDQ
Nov 25, 2024K241831Transpara (2.1.0)
Screenpoint Medical B.V., NL
QDQ
Dec 11, 2023K232096Transpara Density 1.0.0
Screenpoint Medical B.V., NL
QIH
Aug 3, 2022K221347Transpara 1.7.2
Screenpoint Medical B.V., NL
QDQ
Jun 2, 2021K210404Transpara 1.7.0
Screenpoint Medical B.V., NL
QDQ
Mar 5, 2020K193229Transpara
Screenpoint Medical B.V., NL
QDQ
Dec 10, 2019K192287Transpara
Screenpoint Medical B.V., NL
QDQ
Nov 21, 2018K181704Transpara
Screenpoint Medical B.V., NL
QDQ

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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