VOYAGER PERSONAL IMAGING DEVICE— 510(k) K050551

Substantially Equivalent

Ardent Sound, Inc.

FDA 510(k) clearance K050551 for VOYAGER PERSONAL IMAGING DEVICE, Substantially Equivalent on 2005-03-22. Applicant: Ardent Sound, Inc..

Clearance details

Applicant: Ardent Sound, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2005-03-03
Decision date: 2005-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesa, AZ, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.