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FDA 510(k)

3-D IMAGING WORKSTATION

K-Number: K081093 · 2008-05-01

ApplicantEigen, LLC
Decision Date2008-05-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3-D IMAGING WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Eigen, LLC. It received FDA 510(k) clearance on 2008-05-01 under 510(k) number K081093. 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 3-D IMAGING WORKSTATION?

3-D IMAGING WORKSTATION is a medical device that received FDA 510(k) clearance on 2008-05-01. The listed applicant is Eigen, LLC. The 510(k) number is K081093.

When did 3-D IMAGING WORKSTATION receive FDA 510(k) clearance?

3-D IMAGING WORKSTATION received FDA 510(k) clearance on 2008-05-01, under 510(k) number K081093.

Who is the listed applicant for 3-D IMAGING WORKSTATION?

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

What is the FDA product code for 3-D IMAGING WORKSTATION?

The FDA product code for 3-D IMAGING WORKSTATION is LLZ.

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Other records listing Eigen, LLC 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.

K082341DSA 2000EX

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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