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FDA 510(k)

EPIGRAY

K-Number: K112723 · 2012-02-08

ApplicantDosisoft SA
Decision Date2012-02-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EPIGRAY is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft SA. It received FDA 510(k) clearance on 2012-02-08 under 510(k) number K112723. 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 EPIGRAY?

EPIGRAY is a medical device that received FDA 510(k) clearance on 2012-02-08. The listed applicant is Dosisoft SA. The 510(k) number is K112723.

When did EPIGRAY receive FDA 510(k) clearance?

EPIGRAY received FDA 510(k) clearance on 2012-02-08, under 510(k) number K112723.

Who is the listed applicant for EPIGRAY?

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

What is the FDA product code for EPIGRAY?

The FDA product code for EPIGRAY is MUJ.

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Other records listing Dosisoft SA 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.

K252937ThinkQA 3K241765PLANET Onco Dose (3.2)K231573ThinkQA (Edition 2)K103146ISOGRAY TREATMENT PLANNING SYSTEM

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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