RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3— 510(k) K032924

Name: FDA 510(k) clearance K032924
Creator: U.S. Food and Drug Administration
Published: 2003-10-10

Substantially Equivalent

Volume Interactions Pte, Ltd.

FDA 510(k) clearance K032924 for RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3, Substantially Equivalent on 2003-10-10. Applicant: Volume Interactions Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Volume Interactions Pte, Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2003-09-22
Decision date: 2003-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.