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FDA 510(k)

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS

K-Number: K925094 · 1993-09-29

ApplicantGendex Corp.
Decision Date1993-09-29
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1993-09-29 under 510(k) number K925094. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS?

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS is a medical device that received FDA 510(k) clearance on 1993-09-29. The listed applicant is Gendex Corp.. The 510(k) number is K925094.

When did VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS receive FDA 510(k) clearance?

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS received FDA 510(k) clearance on 1993-09-29, under 510(k) number K925094.

Who is the listed applicant for VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS?

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 VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS?

The FDA product code for VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS is EHD.

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Other records listing Gendex Corp. as applicant

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Related Devices (Code: EHD)

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.

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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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