FDA 510(k)

GE LIGHTSPEED XTRA CT SCANNER SYSTEM

K-Number: K060052 · 2006-04-19

Decision Date2006-04-19

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE LIGHTSPEED XTRA 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 2006-04-19 under 510(k) number K060052. 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 LIGHTSPEED XTRA CT SCANNER SYSTEM?

GE LIGHTSPEED XTRA CT SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-19. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K060052.

When did GE LIGHTSPEED XTRA CT SCANNER SYSTEM receive FDA 510(k) clearance?

GE LIGHTSPEED XTRA CT SCANNER SYSTEM received FDA 510(k) clearance on 2006-04-19, under 510(k) number K060052.

Who is the listed applicant for GE LIGHTSPEED XTRA 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 LIGHTSPEED XTRA CT SCANNER SYSTEM?

The FDA product code for GE LIGHTSPEED XTRA 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ge Medical Systems, LLC as applicant

K253560Enhanced Boundary for PCCT K253502Critical Care Suite with Enteric Tube Positioning AI Algorithm K253520Photonova Spectra, Photonova Spectra Select K253780SIGNA™ Bolt K253779SIGNA™ Sprint Select K252379AIR Recon DL

View all 92 devices →

Related Devices (Code: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced 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.