DuraDiagnost X-ray System | Philips Healthcare

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0884838BM287TA Basic UDI-DI 00884838095205UDI-DI	Date27 Nov 2024Registered	StatusActive
United States	GUDID listing GUDID	Number00884838095205 UDI-DI	Date4 Sep 2020Listed	StatusListed GUDID: not in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK201640	Date9 Jul 2020Decided	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK141381	Date12 Jun 2014Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI 0884838BM287TA — open Devices and search for it
AccessGUDID record UDI-DI 00884838095205
FDA 510(k) database 510(k) number K201640
FDA 510(k) database 510(k) number K141381

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 0884838BM287TA registered 27 Nov 2024 Active
FDA 510(k) K201640 decided 9 Jul 2020 Active· +1 more in the status table
FDA GUDID UDI-DI 00884838095205 listed 4 Sep 2020 Listed

Recalls

7 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-1553-2025 FDA Class II initiated 10 Mar 2025
- Ongoing Z-1554-2025 FDA Class II initiated 10 Mar 2025
Potential for collimator to fall as a result of incorrect installation.
- Terminated Z-2322-2017 FDA Class II initiated 31 May 2017
Tube arm assembly could fall down due to cracked welding joints
- Terminated Z-1696-2016 FDA Class II initiated 10 Nov 2015
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
- Terminated Z-2682-2016 FDA Class II initiated 17 Sep 2015
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
- Terminated Z-1555-2015 FDA Class II initiated 9 Feb 2015
The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
- Terminated Z-1251-2015 FDA Class II initiated 23 Jan 2015
Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

Timeline

11 dated events

23 Jan 2015 Recall initiated FDA recalls Z-1251-2015
9 Feb 2015 Recall initiated FDA recalls Z-1555-2015
17 Sep 2015 Recall initiated FDA recalls Z-2682-2016
10 Nov 2015 Recall initiated FDA recalls Z-1696-2016
31 May 2017 Recall initiated FDA recalls Z-2322-2017
9 Jul 2020 Cleared FDA 510(k) K201640
4 Sep 2020 Listed FDA GUDID 00884838095205
27 Nov 2024 Registered EUDAMED 0884838BM287TA
10 Mar 2025 Recall initiated FDA recalls Z-1553-2025
10 Mar 2025 Recall initiated FDA recalls Z-1554-2025

1 earlier event are in the sections above.

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

Full name: Duradiagnost

Generic name: Stationary basic diagnostic x-ray system, digital
Model / Ref / Catalog: 712203, DuraDiagnost

Primary DI / UDI-DI: 00884838095205
Basic UDI-DI: 0884838BM287TA
Direct marketing DI: 00884838095205
510(k) Number: K141381 510(k)
K201640 GUDID
FDA product code: KPR
EMDN code: Z11031101 Multifunctional systems for direct digital radiology
GMDN term: Stationary basic diagnostic x-ray system, digital

Device class: Class IIb EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 892.1680
EU registration type: Standard device
EU market of registration: Germany
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent
GUDID distribution status: Not in Commercial Distribution

Truth per registry

3 sources · 3 fields differ

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED 712203	510(k) —	GUDID DuraDiagnost
510(k) Number	EUDAMED —	510(k) K141381	GUDID K201640
Device class	EUDAMED Class IIb	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Ddrversa Motion K123005 7 Dec 2012 FDA record · FDA summary
Brivo XR385 K103448 12 Aug 2011 FDA record · FDA summary
Philips Bucky Vision K982795 24 Nov 1998 FDA record

Cited by

DuraDiagnost K201640 9 Jul 2020 FDA record · FDA summary
DigitalDiagnost C50 K163410 4 Jan 2017 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 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 DuraDiagnost is a stationary X-ray imaging system designed for radiography. It incorporates key components such as an integrated tube column, a patient table with a floating tabletop, and a high-voltage generator to produce high-quality radiographic images. This system supports dual-focus rotation anode technology for enhanced imaging performance across various clinical applications.

The DuraDiagnost is intended for use in radiology departments and clinical settings requiring stationary X-ray imaging. It is supplied as a reusable, non-sterile device with multiple model and reference codes (e.g., 3003768277, 3009715136). The system complies with FDA 510(k) clearance and MDR authorizations, adhering to regulatory standards for Class II medical devices under product code KPR. Storage and handling follow manufacturer guidelines to ensure optimal performance and safety.

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Properties

Measuring function
Prescription use
Serial number

Other properties (22, all answered No)