# K140342: QCT Pro Asynchronous Calibration Module, Cliniqct

- Pathway: 510(k) (Traditional)
- Applicant: Mindways Software, Inc.
- Decided: Aug 29, 2014 after 199 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883280 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894854: QCT Bone Mineral Density Analysis Software, Image Enhancements (1989) Summary page 4.
- K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip, Mindways Software, Inc. (2001) Summary page 5.
- K030330: Ctxa Hip Extended Reference Data, Mindways Software, Inc. (2003) Summary page 5.

## Indications for use
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure.

Source page: https://510kreport.com/device/K140342
Methodology: https://510kreport.com/methodology