The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Ud 150l-r Ii.
| Device ID | K945453 |
| 510k Number | K945453 |
| Device Name: | UD 150L-R II |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-03-21 |