| Device Classification Name |
Table, Radiologic
|
| 510(k) Number |
K874639 |
| Device Name |
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 |
| Applicant |
| Shimadzu Precision Instruments, Inc. |
| 20410 Earl St. |
|
Torrance,
CA
90503
|
|
| Applicant Contact |
HIROYUKI HATTORI,PHD |
| Correspondent |
| Shimadzu Precision Instruments, Inc. |
| 20410 Earl St. |
|
Torrance,
CA
90503
|
|
| Correspondent Contact |
HIROYUKI HATTORI,PHD |
| Regulation Number | 892.1980 |
| Classification Product Code |
|
| Date Received | 11/12/1987 |
| Decision Date | 12/04/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|