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FDA 510(k)

CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION

K-Number: K880169 · 1988-03-09

ApplicantCemax, Inc.
Decision Date1988-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Cemax, Inc.. It received FDA 510(k) clearance on 1988-03-09 under 510(k) number K880169. 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 CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION?

CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION is a medical device that received FDA 510(k) clearance on 1988-03-09. The listed applicant is Cemax, Inc.. The 510(k) number is K880169.

When did CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION receive FDA 510(k) clearance?

CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION received FDA 510(k) clearance on 1988-03-09, under 510(k) number K880169.

Who is the listed applicant for CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION?

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

What is the FDA product code for CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION?

The FDA product code for CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION is LLZ.

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Other records listing Cemax, 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.

K950513ARCHIVEMANAGERK945188CEMAX VIPSTATION AND/OR SOFTWAREK943357CEMAX SCANLINK VK932371CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWAREK932372CEMAX VIPSTATION(TM) AND/OR SOFTWAREK905801CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO

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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

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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