SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System— 510(k) K202350
Substantially EquivalentShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
FDA 510(k) clearance K202350 for SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System, Substantially Equivalent on 2021-01-06. Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Device class: 2.
Clearance details
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Recent devices under product code IZL
view allMore clearances from Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
view all- K210317 — Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
- K210318 — Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
- K202353 — SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
- K200637 — SR-8100 Portable X-ray Unit
- K200976 — SR-8230, SR-8230S Portable X-ray Unit
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.