Cleared Traditional

K031088 - TRIMED PLAN, VERSION 2.2 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031088 · Trimed Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
476d
Days
Class 2
Risk

K031088 is an FDA 510(k) clearance for the TRIMED PLAN, VERSION 2.2. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Trimed Systems, Inc. (Ballwin, US). The FDA issued a Cleared decision on July 23, 2004 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Trimed Systems, Inc. devices

Submission Details

510(k) Number K031088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date July 23, 2004
Days to Decision 476 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
369d slower than avg
Panel avg: 107d · This submission: 476d
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 251
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K031088.
syngo.via RT Image Suite VC10
K252304 · Varian Medical Systems, Inc. · Mar 2026
Monaco RTP System (6.3)
K252002 · Elekta Solutions AB · Feb 2026
TrueFit Bolus
K260308 · Adaptiiv Medical Technologies, Inc. · Feb 2026
ART-Plan+ (v3.1.0)
K253091 · Therapanacea Sas · Dec 2025
RayStation (2024A SP3)
K252109 · RaySearch Laboratories AB (PUBL) · Dec 2025
ClearCalc Model RADCA V2.6
K252863 · Radformation, Inc. · Dec 2025