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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252579

510(k) cleared

Orthoscan TAU MVP Mini C-Arm System

Ziehm-Orthoscan, Inc. · Jan 14, 2026 · K252579

FDA cleared the Orthoscan TAU MVP Mini C-Arm System from Ziehm-Orthoscan, Inc. on Jan 14, 2026 under K252579, a traditional 510(k). The device falls under product code OXO, Image-Intensified Fluoroscopic X-Ray System, Mobile, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 15, 2025. The decision came 152 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 Ziehm-Orthoscan, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252579?

K252579 is the FDA 510(k) for Orthoscan TAU MVP Mini C-Arm System, submitted by Ziehm-Orthoscan, Inc.. FDA's decision date was Jan 14, 2026, under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile).

Who makes the Orthoscan TAU MVP Mini C-Arm System?

Ziehm-Orthoscan, Inc., based in Scottsdale, AZ, is the applicant of record for K252579.

How long did the K252579 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Jan 14, 2026, 152 days later.

← All decisions in January 2026