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Minicat

by Xoran Technologies, Inc.

510(k) K113421

Minicat is a Class II device made by Xoran Technologies, Inc., cleared under FDA 510(k) K113421 on 11 Jul 2012, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK113421 Date11 Jul 2012ClearedStatusActive

Official records

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

2 dated events

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K113421

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K113421
UDI-DISize and differences
MiniCAT 10004
Xoran Technologies, LLC
1000400860290000308
Prescription: no
On the market
MiniCAT2020 10020
Xoran Technologies, LLC
1002000860290000353
Prescription: no
On the market
MiniCATIQ 10009
Xoran Technologies, LLC
1000900860290000315
Prescription: no
On the market
MiniCATIQ 10015
Xoran Technologies, LLC
1001500860008443731
Prescription: yes
On the market
MiniCATIQ+ 10040
Xoran Technologies, LLC
1004000860008443755
Prescription: yes
On the market

Similar devices

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

Other devices from Xoran Technologies, LLC

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    Class II

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    Class II

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    Class II

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    Class II

See all devices from Xoran Technologies, LLC →