QCT Bone Mineral Density Analysis Software

Basic Information

• Brand Name: QCT Bone Mineral Density Analysis Software
• Primary DI: B052DIQCTPRO0
• Version / Model: K894854
• Catalog Number: DI_QCTPRO
• 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: c16db3fe-1e97-451c-b129-67c13fffa9bc

Device Description

The method of Quantitative Computed Tomography (QCT) has been established as a means of non-invasive quantitative bone mineral determination. The QCT PRO software system allows to map information obtained from executing protocols with commercially available CT scanners to an estimate of bone mineral content. The QCT PRO software system does not interfere directly with a medical device. Its function is to provide a means of entering, storing and obtaining information/data only. A competent health professional is reasonably expected to exercise judgement in the use of the information provided by the system. The QCT PRO software system provides a means of entering or receiving general patient information including age and gender, and information on the CT scanning parameters used in performing the CT scanning protocol. Hounsfield numbers from regions of interest (ROI) of the CT data are processed to provide an estimate of bone mineral density (BMD) for each region of interest (ROI) for which Hounsfield numbers were obtained.

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	B052DIQCTPRO0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K894854	000