DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0— 510(k) K063730

Substantially Equivalent

Volume Interactions Pte, Ltd.

FDA 510(k) clearance K063730 for DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0, Substantially Equivalent on 2007-01-31. Applicant: Volume Interactions Pte, Ltd..

Clearance details

Applicant: Volume Interactions Pte, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-12-18
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Tower, 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.