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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 / November 2025 / K251880

510(k) cleared

Archy Dental Imaging

Archy Dental, Inc. · Nov 21, 2025 · K251880

FDA cleared the Archy Dental Imaging from Archy Dental, Inc. on Nov 21, 2025 under K251880, 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 Jun 18, 2025. The decision came 156 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 Archy Dental, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251880?

K251880 is the FDA 510(k) for Archy Dental Imaging, submitted by Archy Dental, Inc.. FDA's decision date was Nov 21, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the Archy Dental Imaging?

Archy Dental, Inc., based in San Jose, CA, is the applicant of record for K251880.

How long did the K251880 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Nov 21, 2025, 156 days later.

← All decisions in November 2025