Chrysalis Intelligence · Sponsors · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

Shantou, CN · 6 510(k) clearances

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Total clearances
6
2020-06-10 → 2021-08-19
Last 12 months
0
Product codes
2
Most recent
2021-08-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IZL System, X-Ray, Mobile Class II Radiology 4 2021-01-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 2 2021-08-19
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2021-08-19 K210317 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System IYN Class II Radiology
2021-08-18 K210318 Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System IYN Class II Radiology
2021-01-06 K202350 SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System IZL Class II Radiology
2020-12-23 K202353 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System IZL Class II Radiology
2020-07-09 K200637 SR-8100 Portable X-ray Unit IZL Class II Radiology
2020-06-10 K200976 SR-8230, SR-8230S Portable X-ray Unit IZL Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence