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)

GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS

K-Number: K091103 · 2009-06-15

ApplicantHitachi Medical Systems America, Inc.
Decision Date2009-06-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2009-06-15 under 510(k) number K091103. 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 GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS?

GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-06-15. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K091103.

When did GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS receive FDA 510(k) clearance?

GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS received FDA 510(k) clearance on 2009-06-15, under 510(k) number K091103.

Who is the listed applicant for GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS?

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

What is the FDA product code for GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS?

The FDA product code for GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS 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 Hitachi Medical Systems America, 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.

K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K161748SUPRIA w/guideShot OptionK160152Trillium Oval V 5.1 MRI SystemK153547ECHELON Oval V 5.1 MRI SystemK123509SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

View all 95 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.

↑