The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Catheterization Table Ks-60.
| Device ID | K951315 |
| 510k Number | K951315 |
| Device Name: | CATHETERIZATION TABLE KS-60 |
| Classification | Table, Radiographic, Non-tilting, Powered |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Fishback |
| Correspondent | Michael Fishback SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IZZ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-05-11 |