3D IMAGING— 510(k) K923823

Name: FDA 510(k) clearance K923823
Creator: U.S. Food and Drug Administration
Published: 1992-10-30

Substantially Equivalent

Resonex, Inc.

FDA 510(k) clearance K923823 for 3D IMAGING, Substantially Equivalent on 1992-10-30. Applicant: Resonex, Inc.. Device class: 2.

Clearance details

Applicant: Resonex, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1992-07-30
Decision date: 1992-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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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.