TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM— 510(k) K070094

Name: FDA 510(k) clearance K070094
Creator: U.S. Food and Drug Administration
Published: 2007-02-09

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K070094 for TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM, Substantially Equivalent on 2007-02-09. Applicant: Varian Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Varian Medical Systems, Inc.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2007-01-10
Decision date: 2007-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYE

view all

K261718 — EZFluence (RADEZ V2)2026-08-31
K260733 — MRIA Radiation Therapy Information System (MRIA)2026-08-26
K261856 — Halcyon, Ethos Radiotherapy System (5.0)2026-08-03
K252937 — ThinkQA 32026-06-12
K253004 — LUNA 3D2026-06-04

More clearances from Varian Medical Systems, Inc.

view all

K260750 — Virtual Cone (1.0)2026-07-08
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04
K252815 — ProBeam 360 Proton Therapy System v3.02026-04-23
K252304 — syngo.via RT Image Suite VC102026-03-18
K252977 — Halcyon, Ethos Radiotherapy System (5.0)2026-01-21

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.