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FDA 510(k)

ChartCheck

K-Number: K201119 · 2020-06-26

ApplicantRadformation, Inc.
Decision Date2020-06-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ChartCheck is a medical device manufactured by Radformation, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K201119. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ChartCheck?

ChartCheck is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Radformation, Inc.. The 510(k) number is K201119.

When was ChartCheck approved by the FDA?

ChartCheck received FDA 510(k) clearance on 2020-06-26, under approval number K201119.

What company makes ChartCheck?

ChartCheck is manufactured by Radformation, Inc..

What is the FDA product code for ChartCheck?

The FDA product code for ChartCheck is IYE.

Other Devices by Radformation, Inc.

K171352EZFluence K171350Collision Check K200323AutoContour K193640ClearCalc K220598AutoContour Model RADAC V2 K220583ClearCheck Model RADCC V2

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K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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