CARESTREAM Vue PACS
K-Number: K153103 · 2016-02-12
ApplicantCarestream Health, Inc.
Decision Date2016-02-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CARESTREAM Vue PACS is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2016-02-12 under approval number K153103. 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 2016-02-12. It is manufactured by Carestream Health, Inc.. The 510(k) number is K153103.
When was CARESTREAM Vue PACS approved by the FDA?
CARESTREAM Vue PACS received FDA 510(k) clearance on 2016-02-12, under approval number K153103.
What company makes CARESTREAM Vue PACS?
CARESTREAM Vue PACS is manufactured by Carestream Health, Inc..
What is the FDA product code for CARESTREAM Vue PACS?
The FDA product code for CARESTREAM Vue PACS is LLZ.
Other Devices by Carestream Health, Inc.
Related Devices (Code: LLZ)
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.