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 - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
Catalog Number
QCTPROM3ASH
Brand Name
QCT PRO Asynchronous 3D Spine and CTXA-Hip System
Version/Model Number
K894854K002113K030330K140342
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KGI
Product Code Name
Densitometer, Bone
Public Device Record Key
9405314a-63bc-4a8d-a4b3-6b013aeeca52
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |