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MiniCAT2020 10020

by Xoran Technologies, LLC

MiniCAT2020 10020 is a Class II device made by Xoran Technologies, LLC, cleared under FDA 510(k) K113421 on 11 Jul 2012 and listed in FDA GUDID since 16 Jul 2018 (UDI-DI 00860290000353), active as of 22 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K113421

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860290000353 UDI-DI Date16 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK113421 Date11 Jul 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113421 decided 11 Jul 2012 Active
  • FDA GUDID UDI-DI 00860290000353 listed 16 Jul 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1210-2015 FDA Class II initiated 8 Sep 2014

    Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

Timeline

3 dated events

  1. Cleared FDA 510(k) K113421
  2. Recall initiated FDA recalls Z-1210-2015
  3. Listed FDA GUDID 00860290000353

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MiniCAT2020
Generic name
Cone beam computed tomography system, head/neck
Model / reference
10020
Primary DI / UDI-DI
00860290000353
510(k) Number
FDA product code
JAK
GMDN term
Cone beam computed tomography system, head/neck
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cone beam computed tomography system, head/neck

Cleared under the same submission (K113421)

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

Other devices from Xoran Technologies, LLC

  • MiniCAT 2D 10030

    Class II

  • MiniCATIQ 10009

    Class II

  • Xoran Workstation v5.15.5

    Class II

  • Tron 11050

    Class II

See all devices from Xoran Technologies, LLC →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)