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FDA 510(k)

IMAGEACCESS SYSTEM

K-Number: K931454 · 1993-12-14

ApplicantImage Premastering Services, Inc.
Decision Date1993-12-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGEACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Image Premastering Services, Inc.. It received FDA 510(k) clearance on 1993-12-14 under 510(k) number K931454. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGEACCESS SYSTEM?

IMAGEACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1993-12-14. The listed applicant is Image Premastering Services, Inc.. The 510(k) number is K931454.

When did IMAGEACCESS SYSTEM receive FDA 510(k) clearance?

IMAGEACCESS SYSTEM received FDA 510(k) clearance on 1993-12-14, under 510(k) number K931454.

Who is the listed applicant for IMAGEACCESS SYSTEM?

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

What is the FDA product code for IMAGEACCESS SYSTEM?

The FDA product code for IMAGEACCESS SYSTEM is LNH.

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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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