Cleared Traditional

Adaptix Ortho350

K252133 · Adaptix Limited · Radiology
Nov 2025
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K252133 is an FDA 510(k) clearance for the Adaptix Ortho350, a System, X-ray, Tomographic (Class II — Special Controls, product code IZF), submitted by Adaptix Limited (Oxford, GB). The FDA issued a Cleared decision on November 6, 2025, 122 days after receiving the submission on July 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K252133 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2025
Decision Date November 06, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZF — System, X-ray, Tomographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1740