QCT Pro Asynchronous Calibration Module, CliniQCT

Basic Information

• Brand Name: QCT Pro Asynchronous Calibration Module, CliniQCT
• Primary DI: B052DIASYNC0
• Version / Model: K140342
• Catalog Number: DI_ASYNC
• Company Name: MINDWAYS SOFTWARE, INC.
• Labeler DUNS: 964202592
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f18fab86-7641-46a2-911c-fdb6e692e2ff

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGI	Densitometer, Bone	Radiology	892.1170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40867	CT system application software	An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B052DIASYNC0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140342	000