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FDA 510(k)

Merge Universal Viewer (MUV)

K-Number: K250301 · 2025-04-14

ApplicantMerge Healthcare Incorporated
Decision Date2025-04-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Merge Universal Viewer (MUV) 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 2025-04-14 under 510(k) number K250301. 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 Universal Viewer (MUV)?

Merge Universal Viewer (MUV) is a medical device that received FDA 510(k) clearance on 2025-04-14. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K250301.

When did Merge Universal Viewer (MUV) receive FDA 510(k) clearance?

Merge Universal Viewer (MUV) received FDA 510(k) clearance on 2025-04-14, under 510(k) number K250301.

Who is the listed applicant for Merge Universal Viewer (MUV)?

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 Universal Viewer (MUV)?

The FDA product code for Merge Universal Viewer (MUV) 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.

K233326Merge Hemo, Model RCSV2K203104IBM iConnect AccessK192455Merge PACSK192276Merge CardioK182290IBM iConnect AccessK173475Merge PACS

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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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