Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System— 510(k) K173000
Substantially EquivalentShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
FDA 510(k) clearance K173000 for Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System, Substantially Equivalent on 2017-12-07. 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.