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FDA 510(k)

IBM iConnect Access

K-Number: K182290 · 2018-09-25

ApplicantMerge Healthcare Incorporated
Decision Date2018-09-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IBM iConnect Access 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 2018-09-25 under 510(k) number K182290. 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 IBM iConnect Access?

IBM iConnect Access is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K182290.

When did IBM iConnect Access receive FDA 510(k) clearance?

IBM iConnect Access received FDA 510(k) clearance on 2018-09-25, under 510(k) number K182290.

Who is the listed applicant for IBM iConnect Access?

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 IBM iConnect Access?

The FDA product code for IBM iConnect Access 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 CardioK173475Merge 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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