The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Ximatron Scan Vision Ct.
Device ID | K981056 |
510k Number | K981056 |
Device Name: | VARIAN XIMATRON SCAN VISION CT |
Classification | System, X-ray, Stationary |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1120 |
Contact | Linda S Nash |
Correspondent | Linda S Nash VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1120 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-23 |
Decision Date | 1998-06-12 |
Summary: | summary |