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Reveal 35C 1

by KA Imaging Inc

Reveal 35C 1 (101), an indirect flat panel x-ray detector (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by KA Imaging Inc, was cleared under FDA 510(k) K201591 on 3 Sep 2020, registered in EUDAMED and listed in FDA GUDID on 11 Mar 2021 (UDI-DI 16280119411015); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: 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) K201591

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16280119411015 UDI-DI Date11 Mar 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201591 Date3 Sep 2020DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K201591 decided 3 Sep 2020 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 16280119411015 listed 11 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201591
  2. Listed FDA GUDID 16280119411015

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Reveal 35C
Generic name
Indirect flat panel x-ray detector
Model / Ref / Catalog
1, 101
Primary DI / UDI-DI
16280119411015
510(k) Number
FDA product code
MQB
GMDN term
Indirect flat panel x-ray detector
Device class
Class II
Regulation number
892.1680
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from KA Imaging Inc

  • Flat Panel Detector

    Class II

  • Reveal 35C

    Class IIa

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)