XBit Series Digital Color Doppler Ultrasound System— 510(k) K200780
Substantially EquivalentCHISON Medical Technologies Co., Ltd.
FDA 510(k) clearance K200780 for XBit Series Digital Color Doppler Ultrasound System, Substantially Equivalent on 2020-08-05. Applicant: CHISON Medical Technologies Co., Ltd..
Clearance details
- Applicant
- CHISON Medical Technologies Co., Ltd.
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuxi, CN
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.