Cleared Traditional

K112723 - EPIGRAY

K112723 is an FDA 510(k) clearance for EPIGRAY, manufactured by Dosisoft SA. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K112723 · Dosisoft SA · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
142d
Days
Class 2
Risk

K112723 is an FDA 510(k) clearance for the EPIGRAY. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Dosisoft SA (Lincoln, US). The FDA issued a Cleared decision on February 8, 2012 after a review of 142 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 Dosisoft SA devices

FDA 510(k) Submission Details - K112723

510(k) Number K112723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2011
Decision Date February 08, 2012
Days to Decision 142 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
35d slower than avg
Panel avg: 107d · This submission: 142d
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 Consultant

Doslsoft SA
ROBERT J MORTON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 250
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K112723.
SIMUPLAN TREATMENT PLANNING SYSTEM
K120551 · Simuplan S.L. · Jun 2012
RAYSTATION
K120387 · Raysearch Laboratories AB · Apr 2012
SYNGO RT INTERFACE
K120363 · Siemens Medical Solutions USA, Inc. · Mar 2012
RADIANCE
K112060 · Gmv Aerospace and Defence S.A. · Jan 2012
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K112776 · Tomotherapy Incorporated · Dec 2011
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
K113102 · Nucletron · Dec 2011