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FDA 510(k)

ISOGRAY TREATMENT PLANNING SYSTEM

K-Number: K103146 · 2011-03-11

ApplicantDosisoft SA
Decision Date2011-03-11
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOGRAY TREATMENT PLANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft SA. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K103146. 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 ISOGRAY TREATMENT PLANNING SYSTEM?

ISOGRAY TREATMENT PLANNING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Dosisoft SA. The 510(k) number is K103146.

When did ISOGRAY TREATMENT PLANNING SYSTEM receive FDA 510(k) clearance?

ISOGRAY TREATMENT PLANNING SYSTEM received FDA 510(k) clearance on 2011-03-11, under 510(k) number K103146.

Who is the listed applicant for ISOGRAY TREATMENT PLANNING SYSTEM?

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 ISOGRAY TREATMENT PLANNING SYSTEM?

The FDA product code for ISOGRAY TREATMENT PLANNING SYSTEM is MUJ.

Related Clinical Trials

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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)K112723EPIGRAY

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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