The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Cadplan Plus: 3d Treatment Planning System.
Device ID | K992753 |
510k Number | K992753 |
Device Name: | CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
Contact | Linda S Nash |
Correspondent | Linda S Nash VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-16 |
Decision Date | 1999-09-03 |
Summary: | summary |