FDA UDI
In Commercial Distribution
🇺🇸 United States
CORVUS 09
DI: 00852656007045
·
Model: 210293
·
Best Nomos
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORVUS 09
- Primary DI
- 00852656007045
- Version / Model
- 210293
- Company Name
- Best Nomos
- Labeler DUNS
- 146920025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-23
- Public Version
- 1
- Public Version Date
- 2018-09-24
- Public Version Status
- New
- Public Device Record Key
- 2418a90c-7074-475e-a2ff-bc032cb93790
Device Description
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
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
- Yes
- 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 |
|---|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 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 | 00852656007045 | GS1 |
Customer Contacts
- Phone
- (412) 312-6700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100092 | 000 |