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)

GX-C CEPHALOMETER

K-Number: K920189 · 1992-04-28

ApplicantGendex Corp.
Decision Date1992-04-28
Product CodeEAG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GX-C CEPHALOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1992-04-28 under 510(k) number K920189. The device is classified under product code EAG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GX-C CEPHALOMETER?

GX-C CEPHALOMETER is a medical device that received FDA 510(k) clearance on 1992-04-28. The listed applicant is Gendex Corp.. The 510(k) number is K920189.

When did GX-C CEPHALOMETER receive FDA 510(k) clearance?

GX-C CEPHALOMETER received FDA 510(k) clearance on 1992-04-28, under 510(k) number K920189.

Who is the listed applicant for GX-C CEPHALOMETER?

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

What is the FDA product code for GX-C CEPHALOMETER?

The FDA product code for GX-C CEPHALOMETER is EAG.

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 Gendex 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.

K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEMK945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSOR

View all 14 devices →

Related Devices (Code: EAG)

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.

K030699VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRICJ. Morita Mfg. Corp.K021372VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITYJ. Morita USA, Inc.K944162DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMTeledyne Water PikK896099DIGIGRAPH DIAGNOSTIC WORK/STATIONDolphin Imaging SystemsK870243BURNETT TMJ APPLIANCEMedrad, Inc.K842463GX CEPHGendex Corp.

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.

↑