ECLIPSE TREATMENT PLANNING SYSTEM— 510(k) K102011
Substantially EquivalentVarian Medical Systems, Inc.
FDA 510(k) clearance K102011 for ECLIPSE TREATMENT PLANNING SYSTEM, Substantially Equivalent on 2010-09-03. Applicant: Varian Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Varian Medical Systems, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code MUJ
view allMore clearances from Varian Medical Systems, Inc.
view allRecalls naming K102011
K-number listed on FDA's recall record- Z-0867-2013 — Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
- Z-2462-2012 — Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102011.
Data sourced from openFDA. This site is unofficial and independent of the FDA.