The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Sdl-32 Electronic Linear Scanner.
| Device ID | K850834 |
| 510k Number | K850834 |
| Device Name: | SDL-32 ELECTRONIC LINEAR SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHIMADZU CORP. 16921 S WESTERN AVE #102 Gardena, CA 90247 |
| Contact | Takao Someyama |
| Correspondent | Takao Someyama SHIMADZU CORP. 16921 S WESTERN AVE #102 Gardena, CA 90247 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-10-31 |