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FDA 510(k)

TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM

K-Number: K101861 · 2010-12-22

ApplicantTruevision Systems, Incorporated
Decision Date2010-12-22
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Truevision Systems, Incorporated. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K101861. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM?

TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Truevision Systems, Incorporated. The 510(k) number is K101861.

When did TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM receive FDA 510(k) clearance?

TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM received FDA 510(k) clearance on 2010-12-22, under 510(k) number K101861.

Who is the listed applicant for TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM?

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

What is the FDA product code for TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM?

The FDA product code for TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM is HKI.

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Related Devices (Code: HKI)

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.

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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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