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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 / K261531

510(k) cleared

PV-iCurve Pro

Perception Vision Medical Technology Co., Ltd. · Oct 21, 2026 · K261531

FDA cleared the PV-iCurve Pro from Perception Vision Medical Technology Co., Ltd. on Oct 21, 2026 under K261531, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 8, 2026. The decision came 166 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 Perception Vision Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261531?

K261531 is the FDA 510(k) for PV-iCurve Pro, submitted by Perception Vision Medical Technology Co., Ltd.. FDA's decision date was Oct 21, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the PV-iCurve Pro?

Perception Vision Medical Technology Co., Ltd., based in Guangzhou, is the applicant of record for K261531.

How long did the K261531 review take?

FDA received the submission on May 8, 2026 and issued its decision on Oct 21, 2026, 166 days later.

← All decisions in October 2026