The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Ud150l-r X-ray High Voltage Generator.
| Device ID | K934967 |
| 510k Number | K934967 |
| Device Name: | SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Y Fishback |
| Correspondent | Michael Y Fishback SHIMADZU CORP. 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 | 1993-10-15 |
| Decision Date | 1993-12-13 |