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FDA 510(k)

VOLUME VIEWER PLUS

K-Number: K041521 · 2004-06-22

ApplicantGeneral Electric Medical Systems
Decision Date2004-06-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLUME VIEWER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems. It received FDA 510(k) clearance on 2004-06-22 under 510(k) number K041521. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUME VIEWER PLUS?

VOLUME VIEWER PLUS is a medical device that received FDA 510(k) clearance on 2004-06-22. The listed applicant is General Electric Medical Systems. The 510(k) number is K041521.

When did VOLUME VIEWER PLUS receive FDA 510(k) clearance?

VOLUME VIEWER PLUS received FDA 510(k) clearance on 2004-06-22, under 510(k) number K041521.

Who is the listed applicant for VOLUME VIEWER PLUS?

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

What is the FDA product code for VOLUME VIEWER PLUS?

The FDA product code for VOLUME VIEWER PLUS is JAK.

Related Clinical Trials

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Other records listing General Electric Medical Systems 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.

K052897GE DEFINIUM AMX 700, MODEL AMX 700K041267CARDIQ ANALYSIS IIIK041270CT COLONOGRAPHY IIK021780ADVANTAGE SIM 6.0K014058ENTEGRA PE PERSONAL DIGITAL ASSISTANT

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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