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)

VOLUMAX CT IMAGING SYSTEM

K-Number: K982060 · 1998-09-02

ApplicantElscint, Inc.
Decision Date1998-09-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLUMAX CT IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1998-09-02 under 510(k) number K982060. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUMAX CT IMAGING SYSTEM?

VOLUMAX CT IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-02. The listed applicant is Elscint, Inc.. The 510(k) number is K982060.

When did VOLUMAX CT IMAGING SYSTEM receive FDA 510(k) clearance?

VOLUMAX CT IMAGING SYSTEM received FDA 510(k) clearance on 1998-09-02, under 510(k) number K982060.

Who is the listed applicant for VOLUMAX CT IMAGING SYSTEM?

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

What is the FDA product code for VOLUMAX CT IMAGING SYSTEM?

The FDA product code for VOLUMAX CT IMAGING SYSTEM is JAK.

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 Elscint, 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.

K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)K970680GLORY

View all 94 devices →

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, 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.

↑