FDA.report

RADFORMATION, INC.

Matched from indexed company URL: Radformation, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30134105523013410552RADFORMATION, INC.1N2026-01-01261 Madison Avenue, 9th Floor New York NY US 10016

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00850072631004ClearCalc - ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.(844) 723-3675support@radformation.com
00850072631035ChartCheck - The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, treatment imaging, and documentation data.(844) 723-3675support@radformation.com
00850072631059ChartCheck - The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, treatment imaging, and documentation data.(844) 723-3675support@radformation.com
00860001672732AutoContour - AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.(844) 723-3675support@radformation.com
00860001672770ClearCheck V2 - ClearCheck is intended to assist radiation therapy professionals in generating and assessing the quality of radiotherapy treatment plans.ClearCheck is also intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.(844) 723-3675support@radformation.com
00860001672787ClearCalc - ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.(844) 723-3675support@radformation.com
00860001672794EZFluence - EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.(844) 723-3675support@radformation.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2038411450726972K260509AutoContour (RADAC V5)QKB2026-03-19
2038411778702846K253962ClearCheck (RADCC V2.7)IYE2026-04-03
2038411122637411K252988ChartCheck (RADCH V1.6)IYE2026-01-05
2038412049533773K252863ClearCalc Model RADCA V2.6MUJ2025-12-19
2038411899697293K242729AutoContour (Model RADAC V4)QKB2024-12-09
2038411789911625K230685AutoContour Model RADAC V3QKB2023-04-14
2038411659421684K220583ClearCheck Model RADCC V2IYE2022-08-23
2038411119613822K220582ClearCalc Model RADCA V2MUJ2022-08-22
2038411466734947K201119ChartCheckIYE2020-06-26
2038411377843197K171352EZFluenceIYE2017-12-01
2038411038646714K171350Collision CheckIYE2017-11-29
2038411995735644K162468ClearCheckIYE2016-12-01
2038411094880054

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYE72026-04-03
QKB32026-03-19
MUJ22025-12-19

PMN

GUDID