Adaptix Ortho350— 510(k) K252133

Substantially Equivalent

Adaptix Limited

FDA 510(k) clearance K252133 for Adaptix Ortho350, Substantially Equivalent on 2025-11-06. Applicant: Adaptix Limited. Device class: 2.

Clearance details

Applicant: Adaptix Limited
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 2025-07-07
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.