Data / Medical devices / United States / Radformation, Inc.
Radformation, Inc.: FDA-registered device maker in New York, NY, United States, 12 510(k) clearances
Radformation, Inc. is registered with the FDA (registration 3013410552) in New York, NY, United States. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 31, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013410552
- Address
- 261 Madison Avenue, 9th Floor, New York, NY, United States, 10016
- Owner or operator
- Radformation, Inc. (10053842)
- Roles
- Manufacturer
- First device listed
- December 22, 2017
- Registered through
- 2027
- Brand names listed
- AutoContour, AutoContour (Model RADAC V4), AutoContour (Model RADAC V5), AutoContour Model RADAC V3, AutoContour Model RADAC V6, AutoContour On-Prem, AutoContour Version 2.3, AutoContour Version 2.4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 31, 2026 | K261718 | EZFluence (RADEZ V2) | IYE | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| August 14, 2026 | K262452 | AutoContour (RADAC V6) | QKB | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| April 3, 2026 | K253962 | ClearCheck (RADCC V2.7) | IYE | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| March 19, 2026 | K260509 | AutoContour (RADAC V5) | QKB | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| January 5, 2026 | K252988 | ChartCheck (RADCH V1.6) | IYE | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| December 19, 2025 | K252863 | ClearCalc Model RADCA V2.6 | MUJ | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| December 9, 2024 | K242729 | AutoContour (Model RADAC V4) | QKB | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| April 14, 2023 | K230685 | AutoContour Model RADAC V3 | QKB | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| August 23, 2022 | K220583 | ClearCheck Model RADCC V2 | IYE | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| August 22, 2022 | K220582 | ClearCalc Model RADCA V2 | MUJ | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| June 26, 2020 | K201119 | ChartCheck | IYE | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
| December 1, 2017 | K171352 | EZFluence | IYE | Substantially Equivalent | Radformation, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of Automated Radiological Image Processing Software
- All makers of Medical Device Data System
Updated August 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.