Radformation, Inc.
New York, NY, US
RADFORMATION, INC. appears in FDA device records in New York, NY. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Radformation, Inc. between 2016 and 2026. The busiest year on record is 2026, with 4. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 2 |
| 2020 | 3 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262452 | AutoContour (RADAC V6) | QKB | Substantially Equivalent | |
| K253962 | ClearCheck (RADCC V2.7) | IYE | Substantially Equivalent | |
| K260509 | AutoContour (RADAC V5) | QKB | Substantially Equivalent | |
| K252988 | ChartCheck (RADCH V1.6) | IYE | Substantially Equivalent | |
| K252863 | ClearCalc Model RADCA V2.6 | MUJ | Substantially Equivalent | |
| K242729 | AutoContour (Model RADAC V4) | QKB | Substantially Equivalent | |
| K230685 | AutoContour Model RADAC V3 | QKB | Substantially Equivalent | |
| K220598 | AutoContour Model RADAC V2 | QKB | Substantially Equivalent | |
| K220583 | ClearCheck Model RADCC V2 | IYE | Substantially Equivalent | |
| K220582 | ClearCalc Model RADCA V2 | MUJ | Substantially Equivalent | |
| K200323 | AutoContour | QKB | Substantially Equivalent | |
| K201119 | ChartCheck | IYE | Substantially Equivalent | |
| K193640 | ClearCalc | MUJ | Substantially Equivalent | |
| K171352 | EZFluence | IYE | Substantially Equivalent | |
| K171350 | Collision Check | IYE | Substantially Equivalent | |
| K162468 | ClearCheck | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013410552 | 3013410552 | RADFORMATION, INC. | 261 Madison Avenue, 9th Floor, New York, NY 10016 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain