Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10— 510(k) K163688
Substantially EquivalentMedisono, LLC
FDA 510(k) clearance K163688 for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10, Substantially Equivalent on 2017-02-23. Applicant: Medisono, LLC.
Clearance details
- Applicant
- Medisono, LLC
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Wilmington, DE, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . 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.