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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 a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2023-10-27 under approval 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. It is manufactured by GE Healthcare. The 510(k) number is K232346.

When was Digital Expert Access with Remote Scanning approved by the FDA?

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

What company makes Digital Expert Access with Remote Scanning?

Digital Expert Access with Remote Scanning is manufactured by GE Healthcare.

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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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41346994 The status quo of the development of decentralized clinical trials. Frontiers in medicine (2025)

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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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