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The Tracker / September 2026 / K254214

510(k) cleared

OOOPDS

Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Sep 15, 2026 · K254214

FDA cleared the OOOPDS from Taiwan Main Orthopaedic Biotechnology Co., Ltd. on Sep 15, 2026 under K254214, 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 29, 2025. The decision came 260 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 Taiwan Main Orthopaedic Biotechnology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254214?

K254214 is the FDA 510(k) for OOOPDS, submitted by Taiwan Main Orthopaedic Biotechnology Co., Ltd.. FDA's decision date was Sep 15, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the OOOPDS?

Taiwan Main Orthopaedic Biotechnology Co., Ltd., based in Taichung, is the applicant of record for K254214.

How long did the K254214 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 15, 2026, 260 days later.

← All decisions in September 2026