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)

4001 CT SCANNER

K-Number: K812393 · 1981-10-13

ApplicantOmnimedical
Decision Date1981-10-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4001 CT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Omnimedical. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812393. 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 4001 CT SCANNER?

4001 CT SCANNER is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Omnimedical. The 510(k) number is K812393.

When did 4001 CT SCANNER receive FDA 510(k) clearance?

4001 CT SCANNER received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812393.

Who is the listed applicant for 4001 CT SCANNER?

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

What is the FDA product code for 4001 CT SCANNER?

The FDA product code for 4001 CT SCANNER 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 Omnimedical 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.

K837378OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEMK820180CALCULI FILTER CUPK812400OMNIMEDICAL QUAD IK802206OMNI SCANNER CT 6000K790673OMNIMEDICAL AUTOMATIC 1001

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.

↑