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)

UXM MODEL 8188

K-Number: K840678 · 1984-03-16

ApplicantUniversal X-Ray
Decision Date1984-03-16
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UXM MODEL 8188 is the device name listed in this FDA 510(k) record. The listed applicant is Universal X-Ray. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840678. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UXM MODEL 8188?

UXM MODEL 8188 is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Universal X-Ray. The 510(k) number is K840678.

When did UXM MODEL 8188 receive FDA 510(k) clearance?

UXM MODEL 8188 received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840678.

Who is the listed applicant for UXM MODEL 8188?

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

What is the FDA product code for UXM MODEL 8188?

The FDA product code for UXM MODEL 8188 is IZX.

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

Related Devices (Code: IZX)

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, 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.

↑