Shantou Institute of Ultrasonic Instruments Co., Ltd.
Shantou Guangdong, CN
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. appears in FDA device records in Shantou Guangdong, CN. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Shantou Institute of Ultrasonic Instruments Co., Ltd. between 2024 and 2026. The busiest year on record is 2024, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253058 | Portable DR Imaging System | IZL | Substantially Equivalent | |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | IYN | Substantially Equivalent | |
| K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017944270 | 3017944270 | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | 3 Longjiang Road, Shantou Guangdong 515000 CN | 2026 | |
| 9615439 | 3003861317 | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. | 77 JINSHA RD., SHANTOU Guangdong 515041 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- PZPFluid Jet Removal System
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IZLSystem, X-Ray, Mobile
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain