510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K140342Substantially Equivalent

Qct Pro Asynchronous Calibration Module, Cliniqct

Mindways Software, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140342 is the FDA 510(k) clearance record for QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT, a class II device, cleared for Mindways Software, Inc. on under FDA product code KGI (Densitometer, Bone). FDA records list 3 510(k) clearances for Mindways Software, Inc., from to . As of , FDA records show no recalls naming K140342.

Clearance record

Decision date
Received
(199 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Mindways Software, Inc. 3001 S Lamar Blvd. Suite 302, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260