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ImagingRing 1.1

by medPhoton GmbH

Ref P01

ImagingRing 1.1 is a device classified as Class IIb in the EU and Class II in the US made by medPhoton GmbH, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI B-19120075320013), cleared under FDA 510(k) K161400 on 8 Dec 2016 and listed in FDA GUDID since 9 Feb 2018 (UDI-DI 19120075320013), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161400

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-19120075320013 Basic UDI-DI 19120075320013UDI-DIDate10 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number19120075320013 UDI-DI Date9 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161400 Date8 Dec 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-19120075320013 registered 10 Jun 2026 Withdrawn
  • FDA 510(k) K161400 decided 8 Dec 2016 Active
  • FDA GUDID UDI-DI 19120075320013 listed 9 Feb 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161400
  2. Listed FDA GUDID 19120075320013
  3. Registered EUDAMED B-19120075320013

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ImagingRing
Generic name
Computed radiography digital imaging scanner
Device name
ImagingRing t
Model / reference
P01 EUDAMED
1.1 GUDID
Primary DI / UDI-DI
19120075320013
Basic UDI-DI
B-19120075320013
510(k) Number
FDA product code
IYE
EMDN code
Z110312, Z11039009
GMDN term
Computed radiography digital imaging scanner
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
P01
GUDID
1.1
Device classEUDAMED
Class IIb
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 GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Computed radiography digital imaging scanner

Cleared under the same submission (K161400)

Similar devices in this category

Other devices filed under FLUOROSCOPY DEVICES.

Other devices from medPhoton GmbH

  • ImagingRing r 1

    Class II

  • ImagingRing 1.2

    Class II

  • Loop-X 1

    Class II

  • ImagingRing System

    Class II

See all devices from medPhoton GmbH →

Properties

  • Serial number
Other properties (22, all answered No)