The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu Whole Body X-ray Ct Scanner Sct-3000tx.
| Device ID | K875370 |
| 510k Number | K875370 |
| Device Name: | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-05-18 |