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FDA 510(k)

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL

K-Number: K945682 · 1995-02-09

ApplicantGendex Corp.
Decision Date1995-02-09
Product CodeEGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K945682. The device is classified under product code EGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL?

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Gendex Corp.. The 510(k) number is K945682.

When did PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL receive FDA 510(k) clearance?

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL received FDA 510(k) clearance on 1995-02-09, under 510(k) number K945682.

Who is the listed applicant for PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL?

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 PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL?

The FDA product code for PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL is EGY.

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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 SYSTEMK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSORK922165ATC725, ATC525, AND AP300

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Related Devices (Code: EGY)

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.

K992896DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc.K955825SMITH S-100 TIME & TEMPERATURE CONTROLSmith Companies Dental ProductsK955643ALARA IMAGING SYSTEMDenoptix, Inc.K900156AP201 DENTAL X-RAY FILM PROCESSORAllied Photo Products Co., Inc.K874118MODEL 410 DENTAL X-RAY FILM PROCESSORSDent-X Co.K811211YOSHIDA AP 100Kaycor Intl., Ltd.

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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