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)

CT PERFUSION OPTION

K-Number: K993791 · 1999-11-24

ApplicantGe Medical Systems, Inc.
Decision Date1999-11-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT PERFUSION OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-11-24 under 510(k) number K993791. 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 CT PERFUSION OPTION?

CT PERFUSION OPTION is a medical device that received FDA 510(k) clearance on 1999-11-24. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K993791.

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

CT PERFUSION OPTION received FDA 510(k) clearance on 1999-11-24, under 510(k) number K993791.

Who is the listed applicant for CT PERFUSION OPTION?

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

What is the FDA product code for CT PERFUSION OPTION?

The FDA product code for 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 Ge Medical Systems, 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.

K091673GE LIGHTSPEED ACT FP16K082104GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEMK042844GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COILK042053INNOVA 4100, INNOVA 3100K040125SENOGRAPHIC STEREOK033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

View all 54 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.

↑