Cleared Special

MILLENNIUM MLC -120

K990085 · Varian Assoc., Inc. · Radiology
Feb 1999
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K990085 is an FDA 510(k) clearance for the MILLENNIUM MLC -120, 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 8, 1999, 28 days after receiving the submission on January 11, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K990085 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1999
Decision Date February 08, 1999
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

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