The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu X-ray High Viltage Generator Ahd150g.
| Device ID | K952822 |
| 510k Number | K952822 |
| Device Name: | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Contact | Masaru Adachi |
| Correspondent | Masaru Adachi SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1995-07-12 |