WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / K260510

510(k) cleared

VenusCT

Linatech, LLC · Oct 19, 2026 · K260510

FDA cleared the VenusCT from Linatech, LLC on Oct 19, 2026 under K260510, a traditional 510(k). The device falls under product code SFV, X-Ray, Computed Tomography, Cone-Beam, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 17, 2026. The decision came 244 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 Linatech, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260510?

K260510 is the FDA 510(k) for VenusCT, submitted by Linatech, LLC. FDA's decision date was Oct 19, 2026, under product code SFV (X-Ray, Computed Tomography, Cone-Beam).

Who makes the VenusCT?

Linatech, LLC, based in Sunnyvale, CA, is the applicant of record for K260510.

How long did the K260510 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Oct 19, 2026, 244 days later.

← All decisions in October 2026