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FDA 510(k)

VIATRONIX V3D EXPLORER

K-Number: K022789 · 2002-09-06

ApplicantViatronix, Inc.
Decision Date2002-09-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIATRONIX V3D EXPLORER is the device name listed in this FDA 510(k) record. The listed applicant is Viatronix, Inc.. It received FDA 510(k) clearance on 2002-09-06 under 510(k) number K022789. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIATRONIX V3D EXPLORER?

VIATRONIX V3D EXPLORER is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is Viatronix, Inc.. The 510(k) number is K022789.

When did VIATRONIX V3D EXPLORER receive FDA 510(k) clearance?

VIATRONIX V3D EXPLORER received FDA 510(k) clearance on 2002-09-06, under 510(k) number K022789.

Who is the listed applicant for VIATRONIX V3D EXPLORER?

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 EXPLORER?

The FDA product code for VIATRONIX V3D EXPLORER is LLZ.

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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 1.2K020658VIATRONIX V3D COLONK013146VIATRONIC V3D CALCIUM SCORING

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Related Devices (Code: LLZ)

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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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