The following data is part of a premarket notification filed by Hamamatsu Photonics, K.k. with the FDA for V2465p X-ray Image Intensifier.
| Device ID | K896331 |
| 510k Number | K896331 |
| Device Name: | V2465P X-RAY IMAGE INTENSIFIER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | HAMAMATSU PHOTONICS, K.K. 360 FOOTHILL RD. BOX 6910 Bridgewater, NJ 08807 |
| Contact | Ralph Eno |
| Correspondent | Ralph Eno HAMAMATSU PHOTONICS, K.K. 360 FOOTHILL RD. BOX 6910 Bridgewater, NJ 08807 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-02 |
| Decision Date | 1989-12-22 |