FDA.reportPublic FDA data

ChartCheck

Primary DI
00850072631035
Brand
ChartCheck
Company
Radformation, Inc
Model
RADCH V1.6
Device description
The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, treatment imaging, and documentation data.
Published
2026-03-13
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
K252988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252988000ChartCheck (RADCH V1.6)Radformation, Inc.2026-01-05IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850072631035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850072631035008500726310358500726310350850072631035

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080444608
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072631097AutoContourVersion 2.82026-08-25
00850072631028ClearCheckVersion 2.72026-05-04
00850072631042AutoContourVersion 2.72026-03-30
00850072631004ClearCalcVersion 2.72026-03-13
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
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