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FDA 510(k)

Merge PACS

K-Number: K192455 · 2019-10-17

ApplicantMerge Healthcare Incorporated
Decision Date2019-10-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Merge PACS is a medical device manufactured by Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2019-10-17 under approval number K192455. 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 Merge PACS?

Merge PACS is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Merge Healthcare Incorporated. The 510(k) number is K192455.

When was Merge PACS approved by the FDA?

Merge PACS received FDA 510(k) clearance on 2019-10-17, under approval number K192455.

What company makes Merge PACS?

Merge PACS is manufactured by Merge Healthcare Incorporated.

What is the FDA product code for Merge PACS?

The FDA product code for Merge PACS is LLZ.

Other Devices by Merge Healthcare Incorporated

K152864Merge Hemo K173475Merge PACS K182290IBM iConnect Access K192276Merge Cardio K203104IBM iConnect Access K233326Merge Hemo, Model RCSV2

View all 8 devices →

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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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