Cleared Traditional

K112776 - TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER

K112776 is an FDA 510(k) clearance for TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER, manufactured by Tomotherapy Incorporated. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K112776 · Tomotherapy Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
87d
Days
Class 2
Risk

K112776 is an FDA 510(k) clearance for the TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Tomotherapy Incorporated (Madison, US). The FDA issued a Cleared decision on December 22, 2011 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K112776

510(k) Number K112776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date December 22, 2011
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K112776.
SYNGO RT INTERFACE
K120363 · Siemens Medical Solutions USA, Inc. · Mar 2012
EPIGRAY
K112723 · Dosisoft SA · Feb 2012
RADIANCE
K112060 · Gmv Aerospace and Defence S.A. · Jan 2012
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
K113102 · Nucletron · Dec 2011
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
K111311 · Omisa Inc. (Segasist Technologies) · Oct 2011
TOMOTHERAPY TREATMENT SYSTEM
K112446 · Tomotherapy Incorporated · Oct 2011
K112776 · TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
Download PDF FDA Summary Tomotherapy Incorpora…