Cleared Traditional

VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C

K904364 · Varian Assoc., Inc. · Radiology
Feb 1991
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K904364 is an FDA 510(k) clearance for the VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 27, 1991, 156 days after receiving the submission on September 24, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K904364 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1990
Decision Date February 27, 1991
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

Similar Devices — IYE Accelerator, Linear, Medical

All 727
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
K252188 · Elekta Solutions AB · Jan 2026
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
K254010 · Brainlab SE · Jan 2026
ChartCheck (RADCH V1.6)
K252988 · Radformation, Inc. · Jan 2026
IDENTIFY (5.0)
K252919 · Varian Medical Systems, Inc. · Dec 2025
ZAP-X Radiosurgery System (ZAP-X)
K250392 · Zap Surgical Systems, Inc. · Nov 2025