QCT PRO Asynchronous 3D Spine Software - Convenience Kit consisting of- QCT Pro - MINDWAYS SOFTWARE, INC.

Duns Number:964202592

Device Description: Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Mineral Density Analysis Software- Accessories

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More Product Details

Catalog Number

QCTPROM0AS

Brand Name

QCT PRO Asynchronous 3D Spine Software

Version/Model Number

K894854K140342

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

K002113,K030330,K140342,K894854

Product Code Details

Product Code

KGI

Product Code Name

Densitometer, Bone

Device Record Status

Public Device Record Key

2d4397d4-9921-4c15-9866-7fd731ba8b72

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