DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY— 510(k) K101008
Substantially EquivalentShantou Institute of Ultrasonic Instruments (Siui
FDA 510(k) clearance K101008 for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY, Substantially Equivalent on 2010-06-08. Applicant: Shantou Institute of Ultrasonic Instruments (Siui.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments (Siui
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.