The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu X-ray High Voltage Generator Ud150k.
| Device ID | K881795 |
| 510k Number | K881795 |
| Device Name: | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-27 |
| Decision Date | 1988-07-01 |