Cleared Traditional

K170969 - Eclipse Treatment Planning System

K170969 is an FDA 510(k) clearance for Eclipse Treatment Planning System, manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K170969 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
96d
Days
Class 2
Risk

K170969 is an FDA 510(k) clearance for the Eclipse Treatment Planning System. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 5, 2017 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K170969

510(k) Number K170969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date July 05, 2017
Days to Decision 96 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 212
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K170969.
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
K170750 · Brainlab AG · Aug 2017
Eclipse Treatment Planning System
K172163 · Varian Medical Systems, Inc. · Aug 2017
Radiance V4
K171885 · Gmv Soluciones Globales Internet S.A.U. · Jul 2017
RayStation
K171536 · RaySearch Laboratories AB (PUBL) · Jun 2017
RayStation 6
K170355 · RaySearch Laboratories AB (PUBL) · Mar 2017
Pinnacle Radiation Therapy Planning System
K170086 · Philips Medical Systems (Cleveland), Inc. · Feb 2017