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FDA 510(k)

Image Suite

K-Number: K251168 · 2025-09-04

ApplicantCarestream Health, Inc.
Decision Date2025-09-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Image Suite 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 2025-09-04 under 510(k) number K251168. 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 Image Suite?

Image Suite is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Carestream Health, Inc.. The 510(k) number is K251168.

When did Image Suite receive FDA 510(k) clearance?

Image Suite received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251168.

Who is the listed applicant for Image Suite?

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 Image Suite?

The FDA product code for Image Suite is LLZ.

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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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