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FDA 510(k)

CARESTREAM IMAGE SUITE

K-Number: K100094 · 2010-03-11

ApplicantCarestream Heatlh, Inc.
Decision Date2010-03-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARESTREAM IMAGE SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Heatlh, Inc.. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K100094. 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 IMAGE SUITE?

CARESTREAM IMAGE SUITE is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Carestream Heatlh, Inc.. The 510(k) number is K100094.

When did CARESTREAM IMAGE SUITE receive FDA 510(k) clearance?

CARESTREAM IMAGE SUITE received FDA 510(k) clearance on 2010-03-11, under 510(k) number K100094.

Who is the listed applicant for CARESTREAM IMAGE SUITE?

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

What is the FDA product code for CARESTREAM IMAGE SUITE?

The FDA product code for CARESTREAM IMAGE SUITE is LLZ.

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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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