Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ClearCheck (RADCC V2.7)

K-Number: K253962 · 2026-04-03

ApplicantRadformation, Inc.
Decision Date2026-04-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearCheck (RADCC V2.7) is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K253962. 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 (RADCC V2.7)?

ClearCheck (RADCC V2.7) is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Radformation, Inc.. The 510(k) number is K253962.

When did ClearCheck (RADCC V2.7) receive FDA 510(k) clearance?

ClearCheck (RADCC V2.7) received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253962.

Who is the listed applicant for ClearCheck (RADCC V2.7)?

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 ClearCheck (RADCC V2.7)?

The FDA product code for ClearCheck (RADCC V2.7) 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)K260509AutoContour (RADAC V5)K252988ChartCheck (RADCH V1.6)K252863ClearCalc Model RADCA V2.6K242729AutoContour (Model RADAC V4)K230685AutoContour Model RADAC V3

View all 16 devices →

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. PychlaK253012AlignRT 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.

↑