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FDA 510(k)

3VISEON/SURGERY

K-Number: K072653 · 2008-01-24

Applicant3Mensio Medical Imaging BV
Decision Date2008-01-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3VISEON/SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is 3Mensio Medical Imaging BV. It received FDA 510(k) clearance on 2008-01-24 under 510(k) number K072653. 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 3VISEON/SURGERY?

3VISEON/SURGERY is a medical device that received FDA 510(k) clearance on 2008-01-24. The listed applicant is 3Mensio Medical Imaging BV. The 510(k) number is K072653.

When did 3VISEON/SURGERY receive FDA 510(k) clearance?

3VISEON/SURGERY received FDA 510(k) clearance on 2008-01-24, under 510(k) number K072653.

Who is the listed applicant for 3VISEON/SURGERY?

The FDA 510(k) record lists 3Mensio Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3VISEON/SURGERY?

The FDA product code for 3VISEON/SURGERY is LLZ.

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Other records listing 3Mensio Medical Imaging BV 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.

K0430973VISEON

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, 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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