# Radformation, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 17 (2016–2026): 17 510(k) clearances
- Names in FDA's records: Radformation, Inc. (16); Radformation (1)
- Product codes: IYE (8), QKB (6), MUJ (3)
- 510(k) review time since 2016: median 104 days, against 120 for FDA's reviews in the same codes and years (10 of 17 faster)
- Predicates its devices cite: 19 (12 its own); citations of its devices by later devices: 14 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Varian Medical Systems, Inc.: 2 (https://510kreport.com/company/varian-medical-systems)
- Mirada Medical, Ltd.: 2 (https://510kreport.com/company/mirada-medical)
- Sun Nuclear Corp.: 1 (https://510kreport.com/company/sun-nuclear)
- Lifeline Software, Inc.: 1 (https://510kreport.com/company/lifeline-software)
- Mobius Medical Systems, LP: 1 (https://510kreport.com/company/mobius-medical-systems)

## Firms that cite its devices most
- Vision Rt, Ltd.: 1 (https://510kreport.com/company/vision-rt)
- Oncosoft. Co., Ltd.: 1 (https://510kreport.com/company/oncosoft)

## Its most-cited devices
- K230685: AutoContour Model RADAC V3 (2023), cited by 2
- K220583: ClearCheck Model RADCC V2 (2022), cited by 2
- K220582: ClearCalc Model RADCA V2 (2022), cited by 1
- K220598: AutoContour Model RADAC V2 (2022), cited by 1
- K162468: ClearCheck (2016), cited by 1
- K201119: ChartCheck (2020), cited by 1

## Recent decisions
- K261718: EZFluence (RADEZ V2) (Aug 31, 2026)
- K262452: AutoContour (RADAC V6) (Aug 14, 2026)
- K253962: ClearCheck (RADCC V2.7) (Apr 3, 2026)
- K260509: AutoContour (RADAC V5) (Mar 19, 2026)
- K252988: ChartCheck (RADCH V1.6) (Jan 5, 2026)
- K252863: ClearCalc Model RADCA V2.6 (Dec 19, 2025)
- K242729: AutoContour (Model RADAC V4) (Dec 9, 2024)
- K230685: AutoContour Model RADAC V3 (Apr 14, 2023)

Source page: https://510kreport.com/company/radformation