SonoBook Series Diagnostic Ultrasound System— 510(k) K170374
Substantially EquivalentChison Medical Imaging Co., Ltd.
FDA 510(k) clearance K170374 for SonoBook Series Diagnostic Ultrasound System, Substantially Equivalent on 2017-06-06. Applicant: Chison Medical Imaging Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Chison Medical Imaging Co., Ltd.
- Product code
- Product 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
- Wuxi, CN
Recent devices under product code IYN
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More clearances from Chison Medical Imaging Co., Ltd.
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- K153085 — Q Series Diagnostic Ultrasound System
- K150861 — QBit Series Diagnostic Ultrasound System
- K140364 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
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.