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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262093

510(k) cleared

Accuro XV

Rivanna Medical, Inc. · Oct 20, 2026 · K262093 · In the directory

FDA cleared the Accuro XV from Rivanna Medical, Inc. on Oct 20, 2026 under K262093, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 22, 2026. The decision came 120 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rivanna Medical, Inc. has 3 other decisions in the tracker over the last 12 months: K253452 (Accuro 3S), K261014 (Accuro® 3S Needle Guide Kit), K254021 (Accuro XV).

Questions & Answers

What did FDA clear under K262093?

K262093 is the FDA 510(k) for Accuro XV, submitted by Rivanna Medical, Inc.. FDA's decision date was Oct 20, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the Accuro XV?

Rivanna Medical, Inc., based in Charlottesville, VA, is the applicant of record for K262093. The company is listed in the MedDevice Startups directory.

How long did the K262093 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Oct 20, 2026, 120 days later.

← All decisions in October 2026

Sources

In the startup directory

Rivanna Medical

Imaging & Radiology · Charlottesville, VA