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FDA 510(k)

VISAGE PACS, VERSION 6.0/CS 3.1

K-Number: K082269 · 2008-12-12

ApplicantVisage Imaging, Inc.
Decision Date2008-12-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISAGE PACS, VERSION 6.0/CS 3.1 is the device name listed in this FDA 510(k) record. The listed applicant is Visage Imaging, Inc.. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K082269. 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 VISAGE PACS, VERSION 6.0/CS 3.1?

VISAGE PACS, VERSION 6.0/CS 3.1 is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Visage Imaging, Inc.. The 510(k) number is K082269.

When did VISAGE PACS, VERSION 6.0/CS 3.1 receive FDA 510(k) clearance?

VISAGE PACS, VERSION 6.0/CS 3.1 received FDA 510(k) clearance on 2008-12-12, under 510(k) number K082269.

Who is the listed applicant for VISAGE PACS, VERSION 6.0/CS 3.1?

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

What is the FDA product code for VISAGE PACS, VERSION 6.0/CS 3.1?

The FDA product code for VISAGE PACS, VERSION 6.0/CS 3.1 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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