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Flaatz 560

by Drtech Corp.

Flaatz 560 is a Class II device made by Drtech Corp., cleared under FDA 510(k) K111583 on 4 Oct 2011 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 08800018403808), 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) K111583

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 Number08800018403808 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK111583 Date4 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111583 decided 4 Oct 2011 Active
  • FDA GUDID UDI-DI 08800018403808 listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111583
  2. Listed FDA GUDID 08800018403808

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flaatz
Generic name
Diagnostic x-ray digital imaging conversion system
Model / reference
FLAATZ 560
Primary DI / UDI-DI
08800018403808
510(k) Number
FDA product code
MQB
GMDN term
Diagnostic x-ray digital imaging conversion system
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Diagnostic x-ray digital imaging conversion system

Similar devices

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

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

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