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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 / July 2026 / K260303

510(k) cleared

See-Mode Augmented Reporting Tool, Breast (SMART-B)

See-Mode Technologies Pty, Ltd. · Jul 28, 2026 · K260303

FDA cleared the See-Mode Augmented Reporting Tool, Breast (SMART-B) from See-Mode Technologies Pty, Ltd. on Jul 28, 2026 under K260303, a traditional 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 Jan 30, 2026. The decision came 179 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 See-Mode Technologies Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260303?

K260303 is the FDA 510(k) for See-Mode Augmented Reporting Tool, Breast (SMART-B), submitted by See-Mode Technologies Pty, Ltd.. FDA's decision date was Jul 28, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the See-Mode Augmented Reporting Tool, Breast (SMART-B)?

See-Mode Technologies Pty, Ltd., based in Melbourne, is the applicant of record for K260303.

How long did the K260303 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Jul 28, 2026, 179 days later.

← All decisions in July 2026