OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K000034
Substantially EquivalentOptimal Imaging Systems, Inc.
FDA 510(k) clearance K000034 for OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2000-02-24. Applicant: Optimal Imaging Systems, Inc..
Clearance details
- Applicant
- Optimal Imaging Systems, Inc.
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, 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.