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FDA 510(k)

Merge PACS

K-Number: K173475 · 2017-12-08

ApplicantMerge Healthcare Incorporated
Decision Date2017-12-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Merge PACS is the device name listed in this FDA 510(k) record. The listed applicant is Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K173475. 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 2017-12-08. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K173475.

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

Merge PACS received FDA 510(k) clearance on 2017-12-08, under 510(k) number K173475.

Who is the listed applicant for Merge PACS?

The FDA 510(k) record lists Merge Healthcare Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merge PACS?

The FDA product code for Merge PACS is LLZ.

Other records listing Merge Healthcare Incorporated as applicant

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.

K250301Merge Universal Viewer (MUV)K233326Merge Hemo, Model RCSV2K203104IBM iConnect AccessK192455Merge PACSK192276Merge CardioK182290IBM iConnect Access

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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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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