DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR— 510(k) K092907
Substantially EquivalentShantou Institute of Ultrasonic Instuments
FDA 510(k) clearance K092907 for DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR, Substantially Equivalent on 2010-03-05. Applicant: Shantou Institute of Ultrasonic Instuments. Device class: 2.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instuments
- Product code
- Code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
Recent devices under product code IYN
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- K262311 — Alturion Series Diagnostic Ultrasound System
- K261288 — Handheld Ultrasound Scanner
More clearances from Shantou Institute of Ultrasonic Instuments
view allAdverse 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.