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SafeCT 1.2

by Medic Vision Imaging Solutions

SafeCT 1.2 is a Class II device made by Medic Vision Imaging Solutions, cleared under FDA 510(k) K100372 on 14 Dec 2010 and listed in FDA GUDID since 1 Feb 2018 (UDI-DI 07290016836004), 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) K100372

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 Number07290016836004 UDI-DI Date1 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100372 Date14 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100372 decided 14 Dec 2010 Active
  • FDA GUDID UDI-DI 07290016836004 listed 1 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100372
  2. Listed FDA GUDID 07290016836004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SafeCT
Generic name
CT system application software
Model / reference
1.2
Primary DI / UDI-DI
07290016836004
510(k) Number
FDA product code
LLZ
GMDN term
CT system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: CT system application software

Other devices from Medic Vision Imaging Solutions

  • iQMR 1.2

    Class II

  • SafeCT-29 1.0

    Class II

  • iQMR

    Class II

  • SafeCT-29

    Class II

Properties

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