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Model 4 CT Calibration Phantom

by Mindways Software, Inc.

Model 4 CT Calibration Phantom is a bone densitometry x-ray phantom (FDA Class II; FDA product code KGI, Densitometer, Bone) made by Mindways Software, Inc., cleared under FDA 510(k) K140342 on 29 Aug 2014 (3 earlier submissions) and listed in FDA GUDID since 4 May 2023 (UDI-DI B052PHCTM40), active as of 14 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 14 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 14 Oct 2026.

Regulatory status

as of registry sync 14 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB052PHCTM40 UDI-DI Date4 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140342 Date29 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140342 decided 29 Aug 2014 Active· +3 more in the status table
  • FDA GUDID UDI-DI B052PHCTM40 listed 4 May 2023 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K894854
  2. Cleared FDA 510(k) K002113
  3. Cleared FDA 510(k) K030330
  4. Cleared FDA 510(k) K140342
  5. Listed FDA GUDID B052PHCTM40

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Bone densitometry x-ray phantom, test object
Model / reference
4
Primary DI / UDI-DI
B052PHCTM40
510(k) Number
FDA product code
KGI
GMDN term
Bone densitometry x-ray phantom, test object
Device class
Class II
Regulation number
892.1170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone densitometry x-ray phantom, test object

Cleared under the same submission (K002113)

and 3 more cleared under K002113

Cleared under the same submission (K030330)

and 3 more cleared under K030330

Similar devices

Also classified as Bone densitometry x-ray phantom, test object.

Similar devices

Other devices filed under FDA product code KGI (Densitometer, Bone).

Other devices from Mindways Software, Inc.

See all devices from Mindways Software, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)