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 a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2025-09-04 under approval 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. It is manufactured by Carestream Health, Inc.. The 510(k) number is K251168.
When was Image Suite approved by the FDA?
Image Suite received FDA 510(k) clearance on 2025-09-04, under approval number K251168.
What company makes Image Suite?
Image Suite is manufactured by Carestream Health, Inc..
What is the FDA product code for Image Suite?
The FDA product code for Image Suite is LLZ.
Related Clinical Trials
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.