ChartCheck
FDA 510(k) K201119 · Radformation, Inc.
510(k) numberK201119
Submission
- Device name
- ChartCheck
- Applicant
- Radformation, Inc.
New York, NY, US - Received
- April 27, 2020
- Decision date
- June 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | Radformation, Inc. | 08/31/2026SE |
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | Manteia Technologies Co., Ltd. | 08/26/2026SE |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 08/03/2026SE |
| K252937 | ThinkQA 3IYE · Traditional | Dosisoft SA | 06/12/2026SE |
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| K252258 | Veriqa RT Epid 3DIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten… | 04/15/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | Radformation, Inc. | 04/03/2026SE |
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More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | 08/31/2026SE |
| K262452 | AutoContour (RADAC V6)QKB · Special | 08/14/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | 04/03/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | 03/19/2026SE |
| K252988 | ChartCheck (RADCH V1.6)IYE · Traditional | 01/05/2026SE |
| K252863 | ClearCalc Model RADCA V2.6MUJ · Traditional | 12/19/2025SE |
| K242729 | AutoContour (Model RADAC V4)QKB · Traditional | 12/09/2024SE |
| K230685 | AutoContour Model RADAC V3QKB · Special | 04/14/2023SE |
| K220598 | AutoContour Model RADAC V2QKB · Traditional | 08/24/2022SE |
| K220583 | ClearCheck Model RADCC V2IYE · Traditional | 08/23/2022SE |
Questions and answers
When was ChartCheck cleared by the FDA?
ChartCheck (K201119) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 60 days after the submission was received.
What is the product code of K201119?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.