The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varis Images, Including Ximatron Digital Imaging Option.
| Device ID | K952313 |
| 510k Number | K952313 |
| Device Name: | VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION |
| Classification | System, Image Processing, Radiological |
| Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. MAIL STOP H-055 Palo Alto, CA 94304 -1129 |
| Contact | Luanne Termeer |
| Correspondent | Luanne Termeer VARIAN ASSOC., INC. 3045 HANOVER ST. MAIL STOP H-055 Palo Alto, CA 94304 -1129 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-17 |
| Decision Date | 1995-08-16 |