Adaptix Ortho350

by Adaptix Limited

510(k) K252133Ref AD01-0850Model Adaptix Ortho350

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252133↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number506106807AD01-0850JE Basic UDI-DI 05061068070003UDI-DI	Date5 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	Number05061068070003 UDI-DI	Date19 Nov 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK252133	Date6 Nov 2025Cleared	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name: Multi-directional tomography x-ray system
Model / Reference: Adaptix Ortho350, AD01-0850

Primary DI / UDI-DI: 05061068070003
Basic UDI-DI: 506106807AD01-0850JE
Direct Marketing DI: 05061068070003
510(k) Number: K252133
FDA Product Code: IZF
EMDN Code: Z11031101 Multifunctional systems for direct digital radiology
GMDN Term: Multi-directional tomography x-ray system

Device Class: Class IIb EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 892.1740
EU market of registration: Ireland
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

Truth per registry

3 sources · 1 field differs

Field	EUDAMED	510(k)	GUDID
Device Class	EUDAMED Class IIb	510(k) Class II	GUDID Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Adaptix Ortho350 is a System, X-Ray, Tomographic device, classified as a Class II medical device under FDA regulations. It is designed for radiographic imaging, enabling detailed visualization of internal structures through computed tomography principles. The system supports orthopedic and musculoskeletal assessments, facilitating precise diagnostic evaluations in radiology settings.

This device is supplied as a reusable system, intended for use in clinical radiology environments. It operates under FDA 510(k) clearance and EU MDR compliance, with a designated advisory committee classification in radiology. The system includes multiple FEI numbers and registration identifiers, reflecting its regulatory approvals for tomographic imaging applications. Storage and handling follow standard medical imaging protocols to ensure operational integrity and patient safety.

Properties

Measuring Function
Prescription Use
Serial Number
Manufacturing Date

Other properties (20)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No