FDA Registration
Active
🇺🇸 United States
RADFORMATION, INC.
Reg #: 3013410552
·
FEI: 3013410552
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- RADFORMATION, INC.
- Registration Number
- 3013410552
- FEI Number
- 3013410552
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 261 Madison Avenue, 9th Floor
- City
- New York
- State
- NY
- ZIP
- 10016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252863
Owner / Operator
- Firm Name
- Radformation, Inc.
- Operator Number
- 10053842
- Address
- 261 Madison Avenue, 9th Floor
- City
- New York
- State
- NY
- Postal Code
- 10016
- Country
- US
- Correspondent
- Kurt Sysock
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2026-03-09 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2020-10-22 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-12-22 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-01-15 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2025-01-15 |
Proprietary Names
ClearCalc RADCA V2.6
ClearCalc
ChartCheck
TPSMonthlyQAHelper Hospital MDDS
EZFluence
AutoContour (Model RADAC V4)
AutoContour
ChartCheck (RADCH V1.6)
ClearCheck
AutoContour (Model RADAC V5)
ClearCheck (RADCC V2.7)
Establishment Types
Manufacture Medical Device