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)

IMAGER, BODY SECTION, RADIONUCLIDE

K-Number: K780395 · 1978-03-31

ApplicantUnion Carbide Corp.
Decision Date1978-03-31
Product CodeIYW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGER, BODY SECTION, RADIONUCLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1978-03-31 under 510(k) number K780395. The device is classified under product code IYW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGER, BODY SECTION, RADIONUCLIDE?

IMAGER, BODY SECTION, RADIONUCLIDE is a medical device that received FDA 510(k) clearance on 1978-03-31. The listed applicant is Union Carbide Corp.. The 510(k) number is K780395.

When did IMAGER, BODY SECTION, RADIONUCLIDE receive FDA 510(k) clearance?

IMAGER, BODY SECTION, RADIONUCLIDE received FDA 510(k) clearance on 1978-03-31, under 510(k) number K780395.

Who is the listed applicant for IMAGER, BODY SECTION, RADIONUCLIDE?

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

What is the FDA product code for IMAGER, BODY SECTION, RADIONUCLIDE?

The FDA product code for IMAGER, BODY SECTION, RADIONUCLIDE is IYW.

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 Union Carbide Corp. 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.

K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZER

View all 69 devices →

Related Devices (Code: IYW)

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.

K944684POLYSCAN DIGITAL SCANNERMse Medizintechnik GmbH & Co. KGK895799RECTILINEAR SCANNER MODEL #187-270Atomic Products Corp.K882453POLYSCAN DIGITAL SCANNERMedical and Scientific Enterprises, Inc.

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.

↑