The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Diagnostic Ultrasound System Sarano, Echo View, Shimasonic.
| Device ID | K082224 |
| 510k Number | K082224 |
| Device Name: | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC |
| 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 |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2008-12-15 |
| Summary: | summary |