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FDA 510(k)

GX CEPH

K-Number: K842463 · 1984-08-02

ApplicantGendex Corp.
Decision Date1984-08-02
Product CodeEAG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GX CEPH is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1984-08-02 under 510(k) number K842463. 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 CEPH?

GX CEPH is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Gendex Corp.. The 510(k) number is K842463.

When did GX CEPH receive FDA 510(k) clearance?

GX CEPH received FDA 510(k) clearance on 1984-08-02, under 510(k) number K842463.

Who is the listed applicant for GX CEPH?

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 CEPH?

The FDA product code for GX CEPH is EAG.

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

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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 PikK920189GX-C CEPHALOMETERGendex Corp.K896099DIGIGRAPH DIAGNOSTIC WORK/STATIONDolphin Imaging SystemsK870243BURNETT TMJ APPLIANCEMedrad, 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.

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