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FDA 510(k)

FOCAL SIM

K-Number: K013112 · 2001-12-05

ApplicantComputerized Medical Systems, Inc.
Decision Date2001-12-05
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FOCAL SIM is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-12-05 under 510(k) number K013112. 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 FOCAL SIM?

FOCAL SIM is a medical device that received FDA 510(k) clearance on 2001-12-05. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K013112.

When did FOCAL SIM receive FDA 510(k) clearance?

FOCAL SIM received FDA 510(k) clearance on 2001-12-05, under 510(k) number K013112.

Who is the listed applicant for FOCAL SIM?

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

What is the FDA product code for FOCAL SIM?

The FDA product code for FOCAL SIM is MUJ.

Related Clinical Trials

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Other records listing Computerized Medical Systems, 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.

K110730MONACO RTP SYSTEMK102216XIO RTP SYSTEMK092132XIO RTP SYSTEMK091179MONACO RTP SYSTEM, VMAT OPTIONK080799ATLAS-BASED AUTOSEGMENTATIONK071938MONACO RTP SYSTEM

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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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