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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 the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) 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. The listed applicant is Radformation, Inc.. The 510(k) number is K201119.

When did ChartCheck receive FDA 510(k) clearance?

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

Who is the listed applicant for ChartCheck?

The FDA 510(k) record lists Radformation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ChartCheck?

The FDA product code for ChartCheck is IYE.

Other records listing Radformation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262452AutoContour (RADAC V6)K253962ClearCheck (RADCC V2.7)K260509AutoContour (RADAC V5)K252988ChartCheck (RADCH V1.6)K252863ClearCalc Model RADCA V2.6K242729AutoContour (Model RADAC V4)

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

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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