The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Sdu-700 Phased Array Sector And Linear Scanner.
| Device ID | K873674 |
| 510k Number | K873674 |
| Device Name: | SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER |
| Classification | Transducer, Ultrasonic |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Contact | Takao Someyama |
| Correspondent | Takao Someyama SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-11 |
| Decision Date | 1988-10-07 |