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SafeCT-29 1.0

by Medic Vision Imaging Solutions

SafeCT-29 1.0 is a CT system computer (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Medic Vision Imaging Solutions, cleared under FDA 510(k) K153331 on 17 May 2016 and listed in FDA GUDID since 1 Feb 2018 (UDI-DI 07290016836202), 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) K153331

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 Number07290016836202 UDI-DI Date1 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153331 Date17 May 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153331 decided 17 May 2016 Active
  • FDA GUDID UDI-DI 07290016836202 listed 1 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153331
  2. Listed FDA GUDID 07290016836202

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SafeCT-29
Generic name
CT system computer
Model / reference
1.0
Primary DI / UDI-DI
07290016836202
510(k) Number
FDA product code
JAK
GMDN term
CT system computer
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: CT system computer

Similar devices

Also classified as CT system computer.

Similar devices

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

Other devices from Medic Vision Imaging Solutions

  • SafeCT 1.2

    Class II

  • iQMR 1.2

    Class II

  • iQMR

    Class II

  • SafeCT-29

    Class II

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)