The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian C/d-series Clinacs (clinac 600 C/d).
Device ID | K926321 |
510k Number | K926321 |
Device Name: | VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D) |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
Contact | Charles H Will |
Correspondent | Charles H Will VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-16 |
Decision Date | 1994-08-09 |