FDA UDI
In Commercial Distribution
🇺🇸 United States
QCT PRO Asynchronous 3D Spine and CTXA-Hip System
DI: B052QCTPROM4ASH0
·
Model: K894854K002113K030330K140342
·
MINDWAYS SOFTWARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
11
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- QCT PRO Asynchronous 3D Spine and CTXA-Hip System
- Primary DI
- B052QCTPROM4ASH0
- Version / Model
- K894854K002113K030330K140342
- Catalog Number
- QCTPROM4ASH
- Company Name
- MINDWAYS SOFTWARE, INC.
- Labeler DUNS
- 964202592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 21b567c2-1541-4b16-ab63-427184539701
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGI | Densitometer, Bone | Radiology | 892.1170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B052QCTPROM4ASH0 | HIBCC | ||||
| Package | QCTPROM4ASHN0100 | HIBCC | Carton/Box | 100 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0075 | HIBCC | Carton/Box | 75 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0050 | HIBCC | Carton/Box | 50 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0025 | HIBCC | Carton/Box | 25 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0010 | HIBCC | Carton/Box | 10 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0005 | HIBCC | Carton/Box | 5 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0003 | HIBCC | Carton/Box | 3 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0002 | HIBCC | Carton/Box | 2 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0500 | HIBCC | Carton/Box | 500 | In Commercial Distribution | |
| Package | QCTPROM4ASHN0200 | HIBCC | Carton/Box | 200 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 512 912-0871
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius