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FDA 510(k)

ACCUSOFT, ACCUSOFT XL

K-Number: K062032 · 2006-10-05

ApplicantDirex Systems Corp.
Decision Date2006-10-05
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUSOFT, ACCUSOFT XL is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062032. 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 ACCUSOFT, ACCUSOFT XL?

ACCUSOFT, ACCUSOFT XL is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Direx Systems Corp.. The 510(k) number is K062032.

When did ACCUSOFT, ACCUSOFT XL receive FDA 510(k) clearance?

ACCUSOFT, ACCUSOFT XL received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062032.

Who is the listed applicant for ACCUSOFT, ACCUSOFT XL?

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

What is the FDA product code for ACCUSOFT, ACCUSOFT XL?

The FDA product code for ACCUSOFT, ACCUSOFT XL is MUJ.

Related Clinical Trials

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Other records listing Direx Systems Corp. 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.

K111947DUET MAGNAK102765PRONEXK072529TRACKPORTK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062147INTEGRA SL

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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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