Medical Device Manufacturer · US , New York , NY

Radformation, Inc.

12 submissions · 12 cleared · Since 2017
12
Total
12
Cleared
0
Denied

Radformation, Inc. — FDA 510(k) Submissions

Radformation, Inc. has submitted 12 FDA 510(k) premarket notifications since 2017, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accelerator, Linear, Medical, Radiological Image Processing Software For Radiation Therapy, System, Planning, Radiation Therapy Treatment . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
ChartCheck (RADCH V1.6)
K252988 · IYE Accelerator, Linear, Medical · Radiology
Jan 2026 109d
ClearCalc Model RADCA V2.6
K252863 · MUJ System, Planning, Radiation Therapy Treatment · Radiology
Dec 2025 101d
AutoContour (Model RADAC V4)
K242729 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Dec 2024 90d
AutoContour Model RADAC V3
K230685 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Apr 2023 32d
AutoContour Model RADAC V2
K220598 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Aug 2022 175d
ClearCheck Model RADCC V2
K220583 · IYE Accelerator, Linear, Medical · Radiology
Aug 2022 175d
ClearCalc Model RADCA V2
K220582 · MUJ System, Planning, Radiation Therapy Treatment · Radiology
Aug 2022 174d
AutoContour
K200323 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Oct 2020 263d
ChartCheck
K201119 · IYE Accelerator, Linear, Medical · Radiology
Jun 2020 60d
ClearCalc
K193640 · MUJ System, Planning, Radiation Therapy Treatment · Radiology
Apr 2020 104d
EZFluence
K171352 · IYE Accelerator, Linear, Medical · Radiology
Dec 2017 206d
Collision Check
K171350 · IYE Accelerator, Linear, Medical · Radiology
Nov 2017 204d
Filters
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