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FDA 510(k)

VIATRONIC V3D CALCIUM SCORING

K-Number: K013146 · 2001-12-07

ApplicantViatronix, Inc.
Decision Date2001-12-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIATRONIC V3D CALCIUM SCORING is the device name listed in this FDA 510(k) record. The listed applicant is Viatronix, Inc.. It received FDA 510(k) clearance on 2001-12-07 under 510(k) number K013146. 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 VIATRONIC V3D CALCIUM SCORING?

VIATRONIC V3D CALCIUM SCORING is a medical device that received FDA 510(k) clearance on 2001-12-07. The listed applicant is Viatronix, Inc.. The 510(k) number is K013146.

When did VIATRONIC V3D CALCIUM SCORING receive FDA 510(k) clearance?

VIATRONIC V3D CALCIUM SCORING received FDA 510(k) clearance on 2001-12-07, under 510(k) number K013146.

Who is the listed applicant for VIATRONIC V3D CALCIUM SCORING?

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 VIATRONIC V3D CALCIUM SCORING?

The FDA product code for VIATRONIC V3D CALCIUM SCORING 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.

K083293VIATRONIX V3D-CARDIAC, REVISION 1.0K040126VIATRONIX V3D COLON, REVISION 1.3K033361VIATRONIX V3D VASCULAR, REVISION 1.0K032483VIATRONIX V3D EXPLORER, REVISION 1.2K022789VIATRONIX V3D EXPLORERK020658VIATRONIX V3D COLON

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Related Devices (Code: JAK)

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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 →

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

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