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)

VITREA 2 CT PERFUSION OPTION

K-Number: K003639 · 2001-01-23

ApplicantVital Images, Inc.
Decision Date2001-01-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREA 2 CT PERFUSION OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2001-01-23 under 510(k) number K003639. 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 VITREA 2 CT PERFUSION OPTION?

VITREA 2 CT PERFUSION OPTION is a medical device that received FDA 510(k) clearance on 2001-01-23. The listed applicant is Vital Images, Inc.. The 510(k) number is K003639.

When did VITREA 2 CT PERFUSION OPTION receive FDA 510(k) clearance?

VITREA 2 CT PERFUSION OPTION received FDA 510(k) clearance on 2001-01-23, under 510(k) number K003639.

Who is the listed applicant for VITREA 2 CT PERFUSION OPTION?

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

What is the FDA product code for VITREA 2 CT PERFUSION OPTION?

The FDA product code for VITREA 2 CT PERFUSION OPTION 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 Vital Images, 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.

K181247Vitrea CT Brain PerfusionK182230Multi Modality ViewerK172855Vitrea Advanced Visualization, Version 7.6K163232Vitrea ViewK163574Multi Modality ViewerK161157Vitrea CT Dual Energy Image View

View all 32 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.

↑