AccessGUDID - DEVICE: QCT PRO Asynchronous 3D Spine and CTXA-Hip System (B052QCTPROM4ASH0)

GUDID

Device Identifier (DI) Information

Brand Name: QCT PRO Asynchronous 3D Spine and CTXA-Hip System
Version or Model: K894854K002113K030330K140342
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QCTPROM4ASH
Company Name: MINDWAYS SOFTWARE, INC.

Primary DI Number: B052QCTPROM4ASH0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964202592 *Terms of Use

Device Description: 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 4 Calibration Phantom

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGI	Densitometer, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002113	000
K030330	000
K140342	000
K894854	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21b567c2-1541-4b16-ab63-427184539701
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 31, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
QCTPROM4ASHN0100	100	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0075	75	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0050	50	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0025	25	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0010	10	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0005	5	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0003	3	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0002	2	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0500	500	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box
QCTPROM4ASHN0200	200	B052QCTPROM4ASH0	In Commercial Distribution	Carton/Box