The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Remote-controlled Universal Diag. Table Rs-100.
| Device ID | K874639 |
| 510k Number | K874639 |
| Device Name: | REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 |
| Classification | Table, Radiologic |
| Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Contact | Hiroyuki Hattori,phd |
| Correspondent | Hiroyuki Hattori,phd SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Product Code | KXJ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-12 |
| Decision Date | 1987-12-04 |