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QCT Bone Mineral Density Analysis Software

FDA UDI

Class II (US FDA UDI)

by Mindways Software, Inc.

Identity

Trade Name
QCT Bone Mineral Density Analysis Software FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
K894854 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
DI_QCTPRO FDA UDI
Primary DI / UDI-DI
B052DIQCTPRO0 FDA UDI
510(k) Number
K894854 FDA UDI
FDA Product Code
KGI FDA UDI
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1170 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CT system application software

QCT Bone Mineral Density Analysis Software by Mindways Software, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CT system application software.

Cleared under the same submission

K894854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mindways Software, Inc.

Sources (1)

  • FDA UDI c16db3fe-1e97-451c-b129-67c13fffa9bc 36 fields · synced Jun 9, 2026