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 / February 2026 / K252649

510(k) cleared

TAP2D

Nano-X Imaging , Ltd. · Feb 2, 2026 · K252649

FDA cleared the TAP2D from Nano-X Imaging , Ltd. on Feb 2, 2026 under K252649, a traditional 510(k). The device falls under product code IZF, System, X-Ray, Tomographic, regulated at 21 CFR 892.1740 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 21, 2025. The decision came 165 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 Nano-X Imaging , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252649?

K252649 is the FDA 510(k) for TAP2D, submitted by Nano-X Imaging , Ltd.. FDA's decision date was Feb 2, 2026, under product code IZF (System, X-Ray, Tomographic).

Who makes the TAP2D?

Nano-X Imaging , Ltd., based in Petah Tikva, is the applicant of record for K252649.

How long did the K252649 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Feb 2, 2026, 165 days later.

← All decisions in February 2026