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FDA 510(k)

ClearCheck

K-Number: K162468 · 2016-12-01

ApplicantRadformation
Decision Date2016-12-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearCheck is the device name listed in this FDA 510(k) record. The listed applicant is Radformation. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K162468. 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 ClearCheck?

ClearCheck is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Radformation. The 510(k) number is K162468.

When did ClearCheck receive FDA 510(k) clearance?

ClearCheck received FDA 510(k) clearance on 2016-12-01, under 510(k) number K162468.

Who is the listed applicant for ClearCheck?

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

What is the FDA product code for ClearCheck?

The FDA product code for ClearCheck is IYE.

Other records listing Radformation 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.

K253962ClearCheck (RADCC V2.7)K260509AutoContour (RADAC V5)K252988ChartCheck (RADCH V1.6)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.

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.K253012AlignRT Plus (8.0)Vision Rt, Ltd.

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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