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FDA 510(k)

RADCALC SOFTWARE, VERSION 6.0

K-Number: K090531 · 2009-05-27

ApplicantLifeline Software, Inc.
Decision Date2009-05-27
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADCALC SOFTWARE, VERSION 6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Lifeline Software, Inc.. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K090531. 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 RADCALC SOFTWARE, VERSION 6.0?

RADCALC SOFTWARE, VERSION 6.0 is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Lifeline Software, Inc.. The 510(k) number is K090531.

When did RADCALC SOFTWARE, VERSION 6.0 receive FDA 510(k) clearance?

RADCALC SOFTWARE, VERSION 6.0 received FDA 510(k) clearance on 2009-05-27, under 510(k) number K090531.

Who is the listed applicant for RADCALC SOFTWARE, VERSION 6.0?

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

What is the FDA product code for RADCALC SOFTWARE, VERSION 6.0?

The FDA product code for RADCALC SOFTWARE, VERSION 6.0 is MUJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Lifeline Software, 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.

K193381RadCalc SoftwareK010464RADCALC, MODEL V.4.0

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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