Adaptix Ortho350

FDA 510(k) K252133 · Adaptix Limited

Substantially Equivalent

510(k) numberK252133

Submission

Device name
Adaptix Ortho350
Applicant
Adaptix Limited
Oxford, GB
Received
July 7, 2025
Decision date
November 6, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
IZF – System, X-Ray, Tomographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1740
Specialty
Radiology

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Questions and answers

When was Adaptix Ortho350 cleared by the FDA?

Adaptix Ortho350 (K252133) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 122 days after the submission was received.

What is the product code of K252133?

The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.