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FDA 510(k)

VIATRONIX V3D-CARDIAC, REVISION 1.0

K-Number: K083293 · 2008-12-05

ApplicantViatronix, Inc.
Decision Date2008-12-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIATRONIX V3D-CARDIAC, REVISION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Viatronix, Inc.. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K083293. 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 VIATRONIX V3D-CARDIAC, REVISION 1.0?

VIATRONIX V3D-CARDIAC, REVISION 1.0 is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Viatronix, Inc.. The 510(k) number is K083293.

When did VIATRONIX V3D-CARDIAC, REVISION 1.0 receive FDA 510(k) clearance?

VIATRONIX V3D-CARDIAC, REVISION 1.0 received FDA 510(k) clearance on 2008-12-05, under 510(k) number K083293.

Who is the listed applicant for VIATRONIX V3D-CARDIAC, REVISION 1.0?

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

What is the FDA product code for VIATRONIX V3D-CARDIAC, REVISION 1.0?

The FDA product code for VIATRONIX V3D-CARDIAC, REVISION 1.0 is JAK.

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Other records listing Viatronix, 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.

K040126VIATRONIX V3D COLON, REVISION 1.3K033361VIATRONIX V3D VASCULAR, REVISION 1.0K032483VIATRONIX V3D EXPLORER, REVISION 1.2K022789VIATRONIX V3D EXPLORERK020658VIATRONIX V3D COLONK013146VIATRONIC V3D CALCIUM SCORING

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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

View on FDA Database →

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