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FDA 510(k)

Carestream Vue PACS

K-Number: K170580 · 2017-04-11

ApplicantCarestream Health, Inc.
Decision Date2017-04-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Carestream Vue PACS is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K170580. 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 Carestream Vue PACS?

Carestream Vue PACS is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is Carestream Health, Inc.. The 510(k) number is K170580.

When did Carestream Vue PACS receive FDA 510(k) clearance?

Carestream Vue PACS received FDA 510(k) clearance on 2017-04-11, under 510(k) number K170580.

Who is the listed applicant for Carestream Vue PACS?

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

What is the FDA product code for Carestream Vue PACS?

The FDA product code for Carestream Vue PACS is LLZ.

Other records listing Carestream Health, Inc. as applicant

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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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