Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO

K-Number: K905801 · 1991-03-22

ApplicantCemax, Inc.
Decision Date1991-03-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO is the device name listed in this FDA 510(k) record. The listed applicant is Cemax, Inc.. It received FDA 510(k) clearance on 1991-03-22 under 510(k) number K905801. 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 SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO?

CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO is a medical device that received FDA 510(k) clearance on 1991-03-22. The listed applicant is Cemax, Inc.. The 510(k) number is K905801.

When did CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO receive FDA 510(k) clearance?

CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO received FDA 510(k) clearance on 1991-03-22, under 510(k) number K905801.

Who is the listed applicant for CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO?

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 SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO?

The FDA product code for CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO is LLZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SOFTWAREK880169CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION

View all 7 devices →

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.

↑