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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 / September 2025 / K251931

510(k) cleared

BioTraceIO Vision (V1.7)

Techsomed Medical Technologies · Sep 8, 2025 · K251931

FDA cleared the BioTraceIO Vision (V1.7) from Techsomed Medical Technologies on Sep 8, 2025 under K251931, a traditional 510(k). The device falls under product code QTZ, Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 24, 2025. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Techsomed Medical Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251931?

K251931 is the FDA 510(k) for BioTraceIO Vision (V1.7), submitted by Techsomed Medical Technologies. FDA's decision date was Sep 8, 2025, under product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation).

Who makes the BioTraceIO Vision (V1.7)?

Techsomed Medical Technologies, based in Or Yehuda, is the applicant of record for K251931.

How long did the K251931 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Sep 8, 2025, 76 days later.

← All decisions in September 2025