Medical Device Manufacturer · US , New York , NY

Radformation, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2017

Official Website

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Radformation, Inc. Radiology ✕

14 devices

1-14 of 14

Cleared Apr 03, 2026

ClearCheck (RADCC V2.7)

Radiology · 113d

Cleared Mar 19, 2026

AutoContour (RADAC V5)

Radiology · 30d

Cleared Jan 05, 2026

ChartCheck (RADCH V1.6)

Radiology · 109d

Cleared Dec 19, 2025

ClearCalc Model RADCA V2.6

Radiology · 101d

Cleared Dec 09, 2024

AutoContour (Model RADAC V4)

Radiology · 90d

Cleared Apr 14, 2023

AutoContour Model RADAC V3

Radiology · 32d

Cleared Aug 24, 2022

AutoContour Model RADAC V2

Radiology · 175d

Cleared Aug 23, 2022

ClearCheck Model RADCC V2

Radiology · 175d

Cleared Aug 22, 2022

ClearCalc Model RADCA V2

Radiology · 174d

Cleared Oct 30, 2020

Radiology · 263d

Cleared Jun 26, 2020

Radiology · 60d

Cleared Apr 09, 2020

Radiology · 104d

Cleared Dec 01, 2017

Radiology · 206d

Cleared Nov 29, 2017

Collision Check

Radiology · 204d