Cleared Traditional

K031281 - ERGO SRS

K031281 is an FDA 510(k) clearance for ERGO SRS, manufactured by 3D Line USA, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K031281 · 3D Line USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
245d
Days
Class 2
Risk

K031281 is an FDA 510(k) clearance for the ERGO SRS. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by 3D Line USA, Inc. (Owings Mills, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 245 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.

FDA 510(k) Submission Details - K031281

510(k) Number K031281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2003
Decision Date December 23, 2003
Days to Decision 245 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
138d slower than avg
Panel avg: 107d · This submission: 245d
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 257
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K031281.
ONCENTRA-VISIR
K041719 · Nucletron Corp. · Jul 2004
ACCUSOFT
K040474 · Direx Systems Corp. · Jun 2004
STANDARD IMAGING E.IMRT CALCULATOR
K040688 · Standard Imaging, Inc. · May 2004
PROWESS
K032456 · Prowess, Inc. · Oct 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · Adac Laboratories · Oct 2003
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
K030821 · Simuplan S.L. · Sep 2003
K031281 · ERGO SRS
Download PDF FDA Summary 3D Line USA, Inc.