The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200pro.
| Device ID | K071289 |
| 510k Number | K071289 |
| Device Name: | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Don Karle |
| Correspondent | Don Karle SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-08 |
| Decision Date | 2008-01-09 |
| Summary: | summary |