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

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..

Clearance details

Applicant: Volume Interactions Pte, Ltd.
Product code: Code LLZ
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.