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 / K261748

510(k) cleared

Dental Cone-beam Computed Tomography (mDX-15P Series)

Hefei Meyer Optoelectronic Technology, Inc. · Jul 23, 2026 · K261748

FDA cleared the Dental Cone-beam Computed Tomography (mDX-15P Series) from Hefei Meyer Optoelectronic Technology, Inc. on Jul 23, 2026 under K261748, a traditional 510(k). The device falls under product code OAS, X-Ray, Tomography, Computed, Dental, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 28, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hefei Meyer Optoelectronic Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261748?

K261748 is the FDA 510(k) for Dental Cone-beam Computed Tomography (mDX-15P Series), submitted by Hefei Meyer Optoelectronic Technology, Inc.. FDA's decision date was Jul 23, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Dental Cone-beam Computed Tomography (mDX-15P Series)?

Hefei Meyer Optoelectronic Technology, Inc., based in Hefei, is the applicant of record for K261748.

How long did the K261748 review take?

FDA received the submission on May 28, 2026 and issued its decision on Jul 23, 2026, 56 days later.

← All decisions in July 2026