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FDA 510(k)

PROWESS

K-Number: K032456 · 2003-10-16

ApplicantProwess, Inc.
Decision Date2003-10-16
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROWESS is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2003-10-16 under 510(k) number K032456. 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 PROWESS?

PROWESS is a medical device that received FDA 510(k) clearance on 2003-10-16. The listed applicant is Prowess, Inc.. The 510(k) number is K032456.

When did PROWESS receive FDA 510(k) clearance?

PROWESS received FDA 510(k) clearance on 2003-10-16, under 510(k) number K032456.

Who is the listed applicant for PROWESS?

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

What is the FDA product code for PROWESS?

The FDA product code for PROWESS is MUJ.

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Other records listing Prowess, 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.

K231825Panther TPSK211760Panther OISK193459Panther StereotacticK122616PANTHER OIS/R & V MODEL VERSION 2.0K101076PROWESS PANTHER PROARC, MODEL VERSION 5.0K100801PUMA MODEL VERSION 1.0

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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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