FDA UDI
In Commercial Distribution
🇺🇸 United States
Theraview
DI: 08717953004000
·
Model: C01-01-00
·
Cablon Medical B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Theraview
- Primary DI
- 08717953004000
- Version / Model
- C01-01-00
- Catalog Number
- C01-01-00
- Company Name
- Cablon Medical B.V.
- Labeler DUNS
- 415163591
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-11
- Public Version
- 1
- Public Version Date
- 2024-11-19
- Public Version Status
- New
- Public Device Record Key
- 8529a93f-df46-45cf-a69b-a52a5ba42b77
Device Description
The Theraview software is used in radiation therapy clinics to acquire Megavoltage (MV) and/ or kiloVoltage (kV) images by means of an imaging device, using one of the Cablon Medical accessories EPID, DAR, eDAR or TBI, and perform image registration (i.e. image matching, tracking) or import match results, in order to accurately set up and position patients for treatment
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40887 | Radiation therapy software | An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717953004000 | GS1 |
Customer Contacts
- Phone
- 0334943964
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960510 | 000 |