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FDA 510(k)

MONACO

K-Number: K132971 · 2013-11-20

ApplicantImpac Medical Systems, Inc.
Decision Date2013-11-20
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MONACO is the device name listed in this FDA 510(k) record. The listed applicant is Impac Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K132971. 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 MONACO?

MONACO is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Impac Medical Systems, Inc.. The 510(k) number is K132971.

When did MONACO receive FDA 510(k) clearance?

MONACO received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132971.

Who is the listed applicant for MONACO?

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

What is the FDA product code for MONACO?

The FDA product code for MONACO is MUJ.

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Other records listing Impac 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.

K123230MOSAIQ ONCOLOGY INFORMATION SYSTEMK120067MOSAIQ ONCOLOGY INFORMATION SYSTEMK043412MODIFICATION TO: VIEWSTATIONK013531QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00K011694VIEWSTATIONK991133MLC FIT

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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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