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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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).

This is the only decision on file for FUJIFILM Healthcare Americas Corporation in the last 12 months of the tracker.

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