ClearanceBrief
Company ยท US

Radformation, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (6 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYEAccelerator, Linear, Medical8
QKBRadiological Image Processing Software For Radiation Therapy6
MUJSystem, Planning, Radiation Therapy Treatment3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 31, 2026K261718EZFluence (RADEZ V2)
Radformation, Inc.
IYE
Aug 14, 2026K262452AutoContour (RADAC V6)
Radformation, Inc.
QKB
Apr 3, 2026K253962ClearCheck (RADCC V2.7)
Radformation, Inc.
IYE
Mar 19, 2026K260509AutoContour (RADAC V5)
Radformation, Inc.
QKB
Jan 5, 2026K252988ChartCheck (RADCH V1.6)
Radformation, Inc.
IYE
Dec 19, 2025K252863ClearCalc Model RADCA V2.6
Radformation, Inc.
MUJ
Dec 9, 2024K242729AutoContour (Model RADAC V4)
Radformation, Inc.
QKB
Apr 14, 2023K230685AutoContour Model RADAC V3
Radformation, Inc.
QKB
Aug 24, 2022K220598AutoContour Model RADAC V2
Radformation, Inc.
QKB
Aug 23, 2022K220583ClearCheck Model RADCC V2
Radformation, Inc.
IYE
Aug 22, 2022K220582ClearCalc Model RADCA V2
Radformation, Inc.
MUJ
Oct 30, 2020K200323AutoContour
Radformation, Inc.
QKB
Jun 26, 2020K201119ChartCheck
Radformation, Inc.
IYE
Apr 9, 2020K193640ClearCalc
Radformation, Inc.
MUJ
Dec 1, 2017K171352EZFluence
Radformation, Inc.
IYE
Nov 29, 2017K171350Collision Check
Radformation, Inc.
IYE
Dec 1, 2016K162468ClearCheck
Radformation
IYE

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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