Delivery Analysis

FDA 510(k) K143269 · Accuray Incorporated

Substantially Equivalent

510(k) numberK143269

Submission

Device name
Delivery Analysis
Applicant
Accuray Incorporated
Madison, WI, US
Received
November 13, 2014
Decision date
April 14, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUJ – System, Planning, Radiation Therapy Treatment
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

Other 510(k)s with product code MUJ

510(k)DeviceApplicantDecision
K260750Virtual Cone (1.0)MUJ · Traditional Varian Medical Systems, Inc.07/08/2026SE
K253050RadOncAIMUJ · Traditional Informai06/18/2026SE
K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional Philips Medical Systems Nederland B.V.05/27/2026SE
K252784eXaSkin PlusMUJ · Traditional Anatomical Geometry S.L.05/22/2026SE
K253078ART.1-USMUJ · Traditional Seetreat Pty, Ltd.05/14/2026SE
K252304syngo.via RT Image Suite VC10MUJ · Traditional Varian Medical Systems, Inc.03/18/2026SE
K260308TrueFit BolusMUJ · Special Adaptiiv Medical Technologies, Inc.02/19/2026SE
K252002Monaco RTP System (6.3)MUJ · Traditional Elekta Solutions AB02/19/2026SE
K253091ART-Plan+ (v3.1.0)MUJ · Traditional Therapanacea Sas12/23/2025SE
K252109RayStation (2024A SP3)MUJ · Traditional RaySearch Laboratories AB (PUBL)12/22/2025SE

More from RaySearch Laboratories AB (PUBL)

510(k)DeviceDecision
K223159Radixact Treatment Delivery SystemIYE · Traditional 06/23/2023SE
K212794Accuray Precision Treatment Planning SystemIYE · Special 09/30/2021SE
K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemIYE · Traditional 12/18/2020SE
K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemIYE · Traditional 11/23/2018SE
K171837TomoTherapy Treatment Delivery System with iDMSIYE · Traditional 07/25/2017SE
K171086Accuray Precision Treatment Planning SystemIYE · Traditional 06/08/2017SE
K161146Radixact Treatment Delivery SystemIYE · Traditional 06/24/2016SE
K161144iDMS Data Management SystemIYE · Traditional 06/24/2016SE
K161136Precision Treatment Planning SystemMUJ · Traditional 06/24/2016SE
K152488Onrad Treatment SystemMUJ · Special 09/28/2015SE

Questions and answers

When was Delivery Analysis cleared by the FDA?

Delivery Analysis (K143269) received a 510(k) decision of Substantially Equivalent on April 14, 2015, 152 days after the submission was received.

What is the product code of K143269?

The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.