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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 / June 2026 / K261713

510(k) cleared

Synapse PACS (7.6.0)

FUJIFILM Healthcare Americas Corporation · Jun 18, 2026 · K261713

FDA cleared the Synapse PACS (7.6.0) from FUJIFILM Healthcare Americas Corporation on Jun 18, 2026 under K261713, a special 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 22, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

FUJIFILM Healthcare Americas Corporation has one other decision in the tracker over the last 12 months: K251204 (FUJIFILM Stiffening Wire Device (SW-2000)).

Questions & Answers

What did FDA clear under K261713?

K261713 is the FDA 510(k) for Synapse PACS (7.6.0), submitted by FUJIFILM Healthcare Americas Corporation. FDA's decision date was Jun 18, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Synapse PACS (7.6.0)?

FUJIFILM Healthcare Americas Corporation, based in Lexington, MA, is the applicant of record for K261713.

How long did the K261713 review take?

FDA received the submission on May 22, 2026 and issued its decision on Jun 18, 2026, 27 days later.

← All decisions in June 2026

Sources