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FDA 510(k)

IMAGELINK

K-Number: K112096 · 2011-09-30

ApplicantComputer Programs and Systems, Inc.
Decision Date2011-09-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGELINK is the device name listed in this FDA 510(k) record. The listed applicant is Computer Programs and Systems, Inc.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K112096. 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 IMAGELINK?

IMAGELINK is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Computer Programs and Systems, Inc.. The 510(k) number is K112096.

When did IMAGELINK receive FDA 510(k) clearance?

IMAGELINK received FDA 510(k) clearance on 2011-09-30, under 510(k) number K112096.

Who is the listed applicant for IMAGELINK?

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

What is the FDA product code for IMAGELINK?

The FDA product code for IMAGELINK is LLZ.

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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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