QCT Pro Asynchronous Calibration Module, CliniQCT - The QCT Pro Asynchronous Calibration Module is - MINDWAYS SOFTWARE, INC.

Duns Number:964202592

Device Description: The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method f 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 procedureinvolving 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.

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More Product Details

Catalog Number

DI_ASYNC

Brand Name

QCT Pro Asynchronous Calibration Module, CliniQCT

Version/Model Number

K140342

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140342

Product Code Details

Product Code

KGI

Product Code Name

Densitometer, Bone

Device Record Status

Public Device Record Key

f18fab86-7641-46a2-911c-fdb6e692e2ff

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MINDWAYS SOFTWARE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11