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FDA 510(k)

HDX DIGITAL IMAGING SYSTEM

K-Number: K954055 · 1995-10-24

ApplicantImacom, Inc.
Decision Date1995-10-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDX DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imacom, Inc.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K954055. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDX DIGITAL IMAGING SYSTEM?

HDX DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is Imacom, Inc.. The 510(k) number is K954055.

When did HDX DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

HDX DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1995-10-24, under 510(k) number K954055.

Who is the listed applicant for HDX DIGITAL IMAGING SYSTEM?

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

What is the FDA product code for HDX DIGITAL IMAGING SYSTEM?

The FDA product code for HDX DIGITAL IMAGING SYSTEM is LLZ.

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Related Devices (Code: LLZ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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