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 Hd150g-60.
| Device ID | K874946 |
| 510k Number | K874946 |
| Device Name: | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 20410 EARL ST. Torrance, CA 90503 |
| Contact | Hiroyuki Hattori |
| Correspondent | Hiroyuki Hattori 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 | 1987-12-02 |
| Decision Date | 1988-03-03 |