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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 / August 2026 / K260567

510(k) cleared

EW10-EC02 Endoscopy Support Program

Fujifilm Corporation · Aug 7, 2026 · K260567

FDA cleared the EW10-EC02 Endoscopy Support Program from Fujifilm Corporation on Aug 7, 2026 under K260567, a special 510(k). The device falls under product code QNP, Gastrointesinal Lesion Software Detection System, regulated at 21 CFR 876.1520 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 19, 2026. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K262902 (ECHELON Synergy), K261229 (SCENARIA View Phase 6.0), K261283 (APERTO Lucent MRI System), K253836 (FCT iStream Phase 2).

Questions & Answers

What did FDA clear under K260567?

K260567 is the FDA 510(k) for EW10-EC02 Endoscopy Support Program, submitted by Fujifilm Corporation. FDA's decision date was Aug 7, 2026, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the EW10-EC02 Endoscopy Support Program?

Fujifilm Corporation, based in Ashigarakami-Gun, is the applicant of record for K260567.

How long did the K260567 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Aug 7, 2026, 169 days later.

← All decisions in August 2026