The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array Transducer, Phased Arr.
| Device ID | K092907 |
| 510k Number | K092907 |
| Device Name: | DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396495022 | K092907 | 000 |
| 06938396494056 | K092907 | 000 |
| 06938396491055 | K092907 | 000 |
| 06938396490065 | K092907 | 000 |
| 06938396488000 | K092907 | 000 |