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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K260898

510(k) cleared

Transpara (2.1.0)

Screenpoint Medical B.V. · Aug 14, 2026 · K260898

FDA cleared the Transpara (2.1.0) from Screenpoint Medical B.V. on Aug 14, 2026 under K260898, a special 510(k). The device falls under product code QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 18, 2026. The decision came 149 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Screenpoint Medical B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260898?

K260898 is the FDA 510(k) for Transpara (2.1.0), submitted by Screenpoint Medical B.V.. FDA's decision date was Aug 14, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the Transpara (2.1.0)?

Screenpoint Medical B.V., based in Nijmegen, is the applicant of record for K260898.

How long did the K260898 review take?

FDA received the submission on Mar 18, 2026 and issued its decision on Aug 14, 2026, 149 days later.

← All decisions in August 2026