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)

GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM

K-Number: K082816 · 2008-10-08

ApplicantGe Medical Systems, LLC
Decision Date2008-10-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K082816. 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 GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM?

GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K082816.

When did GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM receive FDA 510(k) clearance?

GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082816.

Who is the listed applicant for GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM?

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

What is the FDA product code for GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM?

The FDA product code for GE BRIGHTSPEED DELIGHT CT SCANNER 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 Ge Medical Systems, 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.

K253560Enhanced Boundary for PCCTK253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmK253520Photonova Spectra, Photonova Spectra SelectK253780SIGNA™ BoltK253779SIGNA™ Sprint SelectK252379AIR Recon DL

View all 92 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.

↑