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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 / K260755

510(k) cleared

OptraSCAN System

Optrascan, Inc. · Jul 2, 2026 · K260755

FDA cleared the OptraSCAN System from Optrascan, Inc. on Jul 2, 2026 under K260755, a traditional 510(k). The device falls under product code NOT, Microscope, Automated, Image Analysis, Operator Intervention, regulated at 21 CFR 864.1860 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Mar 9, 2026. The decision came 115 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 Optrascan, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260755?

K260755 is the FDA 510(k) for OptraSCAN System, submitted by Optrascan, Inc.. FDA's decision date was Jul 2, 2026, under product code NOT (Microscope, Automated, Image Analysis, Operator Intervention).

Who makes the OptraSCAN System?

Optrascan, Inc., based in San Jose, CA, is the applicant of record for K260755.

How long did the K260755 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Jul 2, 2026, 115 days later.

← All decisions in July 2026