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FDA 510(k)

Digital Expert Access with Remote Scanning

K-Number: K232346 · 2023-10-27

ApplicantGE Healthcare
Decision Date2023-10-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Expert Access with Remote Scanning is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232346. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Expert Access with Remote Scanning?

Digital Expert Access with Remote Scanning is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is GE Healthcare. The 510(k) number is K232346.

When did Digital Expert Access with Remote Scanning receive FDA 510(k) clearance?

Digital Expert Access with Remote Scanning received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232346.

Who is the listed applicant for Digital Expert Access with Remote Scanning?

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

What is the FDA product code for Digital Expert Access with Remote Scanning?

The FDA product code for Digital Expert Access with Remote Scanning is LNH.

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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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