FDA UDI
In Commercial Distribution
🇺🇸 United States
Varian Acuity with Conebeam Computed Tomography
DI: 00856545006010
·
Model: 2.1
·
VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
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
- Varian Acuity with Conebeam Computed Tomography
- Primary DI
- 00856545006010
- Version / Model
- 2.1
- Catalog Number
- TM64001000
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 009120817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-04
- Public Version
- 1
- Public Version Date
- 2020-06-12
- Public Version Status
- New
- Public Device Record Key
- 2b7fbd19-46ed-412e-8a89-8447a2a3429a
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 |
|---|---|---|---|---|
| KPQ | System, simulation, radiation therapy | Radiology | 892.5840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35294 | Radiation therapy simulation system | An assembly of diagnostic and radiation therapy devices comprising a radiation therapy simulation system intended for radiation therapy treatment planning applications. It is configured as a diagnostic x-ray system, e.g., fluoroscopic, planar, computed tomography (CT) with associated hardware and software. It is used to localize the field volume to be exposed during radiation therapy and to confirm the position and size of the therapeutic irradiation field produced by a specific set of treatment parameters that have been developed. A radiation therapy treatment planning system (RTTPS) will typically interface to receive the parameters being measured for further use in treatment calculations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856545006010 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033339 | 000 |