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FDA 510(k)

CROSSPLAN / ACCUSOFT-XL V.4.04

K-Number: K063482 · 2006-12-14

ApplicantDirex Systems Corp.
Decision Date2006-12-14
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CROSSPLAN / ACCUSOFT-XL V.4.04 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 2006-12-14 under 510(k) number K063482. 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 CROSSPLAN / ACCUSOFT-XL V.4.04?

CROSSPLAN / ACCUSOFT-XL V.4.04 is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Direx Systems Corp.. The 510(k) number is K063482.

When did CROSSPLAN / ACCUSOFT-XL V.4.04 receive FDA 510(k) clearance?

CROSSPLAN / ACCUSOFT-XL V.4.04 received FDA 510(k) clearance on 2006-12-14, under 510(k) number K063482.

Who is the listed applicant for CROSSPLAN / ACCUSOFT-XL V.4.04?

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 CROSSPLAN / ACCUSOFT-XL V.4.04?

The FDA product code for CROSSPLAN / ACCUSOFT-XL V.4.04 is MUJ.

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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-10K062147INTEGRA SLK062032ACCUSOFT, ACCUSOFT XL

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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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