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FDA 510(k)

ChartCheck (RADCH V1.6)

K-Number: K252988 · 2026-01-05

ApplicantRadformation, Inc.
Decision Date2026-01-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ChartCheck (RADCH V1.6) is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2026-01-05 under 510(k) number K252988. 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 (RADCH V1.6)?

ChartCheck (RADCH V1.6) is a medical device that received FDA 510(k) clearance on 2026-01-05. The listed applicant is Radformation, Inc.. The 510(k) number is K252988.

When did ChartCheck (RADCH V1.6) receive FDA 510(k) clearance?

ChartCheck (RADCH V1.6) received FDA 510(k) clearance on 2026-01-05, under 510(k) number K252988.

Who is the listed applicant for ChartCheck (RADCH V1.6)?

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 (RADCH V1.6)?

The FDA product code for ChartCheck (RADCH V1.6) 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)K252863ClearCalc Model RADCA V2.6K242729AutoContour (Model RADAC V4)K230685AutoContour Model RADAC V3

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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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