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ImagingRing 1.2

by medPhoton GmbH

ImagingRing 1.2 is a Class II device made by medPhoton GmbH, cleared under FDA 510(k) K161400 on 8 Dec 2016 and listed in FDA GUDID since 25 Oct 2018 (UDI-DI 19120075320037), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K161400

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number19120075320037 UDI-DI Date25 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161400 Date8 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161400 decided 8 Dec 2016 Active
  • FDA GUDID UDI-DI 19120075320037 listed 25 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161400
  2. Listed FDA GUDID 19120075320037

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ImagingRing
Generic name
Computed radiography digital imaging scanner
Model / reference
1.2
Primary DI / UDI-DI
19120075320037
510(k) Number
FDA product code
IYE
GMDN term
Computed radiography digital imaging scanner
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Computed radiography digital imaging scanner.

Other devices from medPhoton GmbH

  • ImagingRing r 1

    Class II
  • ImagingRing 1.1

    Class II
  • Loop-X 1

    Class II
  • ImagingRing System

    Class II

See all devices from medPhoton GmbH →

Properties

  • Serial number
Other properties (14, all answered No)