Cleared Traditional

K232799 - syngo.via RT Image Suite

K232799 is the FDA 510(k) clearance for syngo.via RT Image Suite by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K232799 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
227d
Days
Class 2
Risk

K232799 is an FDA 510(k) clearance for the syngo.via RT Image Suite. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on April 26, 2024 after a review of 227 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 K232799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2023
Decision Date April 26, 2024
Days to Decision 227 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
120d slower than avg
Panel avg: 107d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 127
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K232799.
TrueFit Bolus
K243057 · Adaptiiv Medical Technologies, Inc. · Oct 2024
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
K241318 · Adaptiiv Medical Technologies, Inc. · Aug 2024
Radiance V5
K233236 · Gmv Soluciones Globales Internet S.A.U. · May 2024
ART-Plan (v.2.2.0)
K234068 · Therapanacea Sas · Apr 2024
ART-Plan
K232479 · Therapanacea · Dec 2023
Panther TPS
K231825 · Prowess, Inc. · Dec 2023