FDA.reportPublic FDA data

ClearCheck

Primary DI
00850072631028
Brand
ClearCheck
Company
Radformation, Inc
Model
Version 2.7
Device description
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.
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253962000ClearCheck (RADCC V2.7)Radformation, Inc.2026-04-03IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850072631028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850072631028008500726310288500726310280850072631028

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Contacts#

Phone, Email table
PhoneEmail
(844) 723-3675support@radformation.com

Regulatory Flags#

DUNS number
080444608
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072631097AutoContourVersion 2.82026-08-25
00850072631042AutoContourVersion 2.72026-03-30
00850072631004ClearCalcVersion 2.72026-03-13
00850072631035ChartCheckRADCH V1.62026-03-13
00850072631059ChartCheckVersion 1.72026-03-13
00860001672770ClearCheck V2RADCC V22026-03-13
00860001672787ClearCalcRADCA V2.62026-03-13
00860001672794EZFluenceVersion 2.52026-03-13
00860001672725ClearCalc2.02021-10-11
00860001672732AutoContour2.02021-10-11
00860001672701ClearCheck2.02021-10-04
00860001672718EZFluence2.32021-10-04
00860001672749ChartCheck1.22021-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
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07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
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07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
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