Cleared Traditional

K143269 - Delivery Analysis

K143269 is an FDA 510(k) clearance for Delivery Analysis, manufactured by Accuray Incorporated. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K143269 · Accuray Incorporated · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
152d
Days
Class 2
Risk

K143269 is an FDA 510(k) clearance for the Delivery Analysis. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Accuray Incorporated (Madison, US). The FDA issued a Cleared decision on April 14, 2015 after a review of 152 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.

View all Accuray Incorporated devices

FDA 510(k) Submission Details - K143269

510(k) Number K143269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2014
Decision Date April 14, 2015
Days to Decision 152 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
45d slower than avg
Panel avg: 107d · This submission: 152d
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 208
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K143269.
Monaco
K151233 · Impac Medical Systems, Inc. · Jul 2015
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
K141900 · Eckert & Ziegler Bebig GmbH · May 2015
.decimal Astroid Dosimetry App
K150547 · .Decimal, Inc. · May 2015
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108 · Brainlab AG · Dec 2014
RAYSTATION
K141860 · Raysearch Laboratories AB · Oct 2014
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
K141248 · Varian Medical Systems, Inc. · Sep 2014