Cleared Traditional

K080601 - ERGO++ VERSION 1.7

K080601 is an FDA 510(k) clearance for ERGO++ VERSION 1.7, manufactured by 3D Line Medical Systems S.R.L.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K080601 · 3D Line Medical Systems S.R.L. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
95d
Days
Class 2
Risk

K080601 is an FDA 510(k) clearance for the ERGO++ VERSION 1.7. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by 3D Line Medical Systems S.R.L. (Norcross, US). The FDA issued a Cleared decision on June 6, 2008 after a review of 95 days - within the typical 510(k) review window.

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 3D Line Medical Systems S.R.L. devices

FDA 510(k) Submission Details - K080601

510(k) Number K080601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date June 06, 2008
Days to Decision 95 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
12d faster than avg
Panel avg: 107d · This submission: 95d
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 170
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K080601.
PINNACLE3 SMARTARC
K090808 · Philips Medical Systems, Inc. · Apr 2009
ONCENTRA RT VIEWER 1.0
K082642 · Nucletron Corporation · Nov 2008
MODEIFICATION TO IPLAN RT DOSE
K080888 · Brainlab AG · Jun 2008
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K081281 · Nucletron Corporation · May 2008
ONCENTRA GYN
K080929 · Nucletron Corporation · Apr 2008
ECLIPSE TREATMENT PLANNING SYSTEM
K073020 · Varian Medical Systems, Inc. · Dec 2007