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FDA 510(k)

CARESTREAM PACS

K-Number: K110919 · 2011-10-20

ApplicantCarestream Health, Inc.
Decision Date2011-10-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARESTREAM 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 2011-10-20 under 510(k) number K110919. 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 PACS?

CARESTREAM PACS is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Carestream Health, Inc.. The 510(k) number is K110919.

When did CARESTREAM PACS receive FDA 510(k) clearance?

CARESTREAM PACS received FDA 510(k) clearance on 2011-10-20, under 510(k) number K110919.

Who is the listed applicant for CARESTREAM 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 PACS?

The FDA product code for CARESTREAM PACS is LLZ.

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Other records listing Carestream Health, Inc. as applicant

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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

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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