The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu Ceiling-suspended C-arm Ch-50.
| Device ID | K875374 |
| 510k Number | K875374 |
| Device Name: | SHIMADZU CEILING-SUSPENDED C-ARM CH-50 |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Contact | Hiroyuki Hattori |
| Correspondent | Hiroyuki Hattori SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-02-12 |