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510(k) K920189

Device
GX-C CEPHALOMETER
Applicant
GENDEX CORP.
510(k) number
K920189
Product code
EAG  
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-28
Date received
1992-01-15
Regulation
872.1830
Classification name
Cephalometer
Medical specialty
Dental
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GERALD LLEVY
Address
901 W. Oakton St. Des Plaines IL US 60018 60018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030699VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRICJ. Morita Mfg. Corp.2003-05-29
K021372VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITYJ. Morita USA, Inc.2002-06-07
K944162DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMTeledyne Water Pik1994-11-29
K896099DIGIGRAPH DIAGNOSTIC WORK/STATIONDolphin Imaging Systems1991-01-31
K870243BURNETT TMJ APPLIANCEMedrad, Inc.1987-02-24
K842463GX CEPHGendex Corp.1984-08-02
K833006CEPHALOMETER & FIXATORModern Systems, Inc.1984-01-03
K810538PLASTICEPHMorningstar Dental Co.1981-04-29
K781287DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACHSiemens Corp.1978-09-11

Legacy Summary#

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FDA Review#

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