Shantou Institute of Ultrasonic Instuments
Walnut Creek, CA, US
Shantou Institute of Ultrasonic Instuments appears in FDA device records in Walnut Creek, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Shantou Institute of Ultrasonic Instuments between 1997 and 2012. The busiest year on record is 1997, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1999 | 2 |
| 2001 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113613 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM | IYN | Substantially Equivalent | |
| K092907 | DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR | IYN | Substantially Equivalent | |
| K081110 | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K061083 | CTS-7700 | IYO | Substantially Equivalent | |
| K013327 | CTS-415 | IYO | Substantially Equivalent | |
| K012772 | CTS-485 ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K984203 | SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM | IYN | Substantially Equivalent | |
| K984161 | CTS-310(B) | IYO | Substantially Equivalent | |
| K963068 | CTS-200 WITH EZU-PL21 TRANSDUCER | IYO | Substantially Equivalent | |
| K963065 | CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS | IYO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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