The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Sdu 500 Diagnostic Ultrasound Instrument.
| Device ID | K910426 |
| 510k Number | K910426 |
| Device Name: | SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | Yuji Shimizu |
| Correspondent | Yuji Shimizu SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-06-06 |