Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System— 510(k) K160853
Substantially EquivalentShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
FDA 510(k) clearance K160853 for Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System, Substantially Equivalent on 2016-06-27. Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, 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.