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CT Scanner Tsx-301B

by Canon Inc.

CT Scanner Tsx-301B is a Class II device made by Canon Inc., cleared under FDA 510(k) K132813 on 6 Feb 2014 (1 earlier submission) and listed in FDA GUDID since 1 Mar 2026 (UDI-DI 04987670106538), active as of 22 Oct 2026. 2 FDA recalls are 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

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987670106538 UDI-DI Date1 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132813 Date6 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132813 decided 6 Feb 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04987670106538 listed 1 Mar 2026 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1721-2020 FDA Class II initiated 25 Mar 2019

    Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

    • Terminated Z-0015-2016 FDA Class II initiated 8 May 2015

    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

Timeline

5 dated events

  1. Cleared FDA 510(k) K120546
  2. Cleared FDA 510(k) K132813
  3. Recall initiated FDA recalls Z-0015-2016
  4. Recall initiated FDA recalls Z-1721-2020
  5. Listed FDA GUDID 04987670106538

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CT Scanner
Generic name
Full-body CT system
Model / reference
TSX-301B
Primary DI / UDI-DI
04987670106538
510(k) Number
FDA product code
JAK
GMDN term
Full-body CT system
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K132813)

and 5 more cleared under K132813

Similar devices

Other devices filed under FDA product code JAK (System, x-ray, tomography, computed).

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

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