Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
FDA 510(k) clearance K173000 · decided 2017-12-07
Clearance details
- K-number
- K173000
- Device name
- Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Decision
- Substantially Equivalent
- Date received
- 2017-09-27
- Decision date
- 2017-12-07
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shantou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.