Digital Expert Access with Remote Scanning— 510(k) K232346

Name: FDA 510(k) clearance K232346
Creator: U.S. Food and Drug Administration
Published: 2023-10-27

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K232346 for Digital Expert Access with Remote Scanning, Substantially Equivalent on 2023-10-27. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2023-08-04
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31
K261331 — I-Genius (100019400)2026-07-31

More clearances from GE Healthcare

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K253639 — View2026-01-08
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K223212 — Precision DL2023-04-27
K221680 — Xeleris V Processing and Review System2023-03-01
K221932 — Omni Legend2022-09-02

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.