Cleared Traditional

K132935 - ARTISTE SOLUTION WITH SYS_VC10C AND SYN...

K132935 is the FDA 510(k) clearance for ARTISTE SOLUTION WITH SYS_VC10C AND SYN... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K132935 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
156d
Days
Class 2
Risk

K132935 is an FDA 510(k) clearance for the ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGR.... Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Martinez, US). The FDA issued a Cleared decision on February 21, 2014 after a review of 156 days - an extended review cycle.

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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K132935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date February 21, 2014
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

All 315
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K132935.
ARIA RADIATION THERAPY MANAGEMENT
K133572 · Varian Medical Systems, Inc. · Apr 2014
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
K133227 · Varian Medical Systems, Inc. · Mar 2014
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
K132908 · Medtec, Inc. · Mar 2014
VARIAN MULTILEAF COLLIMATOR
K133240 · Varian Medical Systems, Inc. · Jan 2014
UNIQUE
K132705 · Varian Medical Systems, Inc. · Oct 2013
HIGH ENERGY LINEAR ACCELERATOR
K131807 · Varian Medical Systems, Inc. · Oct 2013