WHERE ARE YOU?

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

THE TAPE

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 / July 2026 / K253899

510(k) cleared

3D-Anywhere

Provect.AI · Jul 9, 2026 · K253899

FDA cleared the 3D-Anywhere from Provect.AI on Jul 9, 2026 under K253899, 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 Dec 5, 2025. The decision came 216 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 Provect.AI in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253899?

K253899 is the FDA 510(k) for 3D-Anywhere, submitted by Provect.AI. FDA's decision date was Jul 9, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the 3D-Anywhere?

Provect.AI, based in Los Gatos, CA, is the applicant of record for K253899.

How long did the K253899 review take?

FDA received the submission on Dec 5, 2025 and issued its decision on Jul 9, 2026, 216 days later.

← All decisions in July 2026