Cleared Traditional

K232799 - syngo.via RT Image Suite

K232799 is an FDA 510(k) clearance for syngo.via RT Image Suite, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K232799

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.

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 208
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