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FDA 510(k)

ClearCalc

K-Number: K193640 · 2020-04-09

ApplicantRadformation, Inc.
Decision Date2020-04-09
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearCalc is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K193640. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearCalc?

ClearCalc is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Radformation, Inc.. The 510(k) number is K193640.

When did ClearCalc receive FDA 510(k) clearance?

ClearCalc received FDA 510(k) clearance on 2020-04-09, under 510(k) number K193640.

Who is the listed applicant for ClearCalc?

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 ClearCalc?

The FDA product code for ClearCalc is MUJ.

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: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, 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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