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-1100.
| Device ID | K050510 |
| 510k Number | K050510 |
| Device Name: | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Randal Walker |
| Correspondent | Randal Walker SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| 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 | 2005-03-01 |
| Decision Date | 2005-04-01 |
| Summary: | summary |