RAYAUTOPLAN 1.0— 510(k) K083264

Clearance details

Applicant

Raysearch Laboratories AB

Product code

Code MUJ

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2008-11-05

Decision date

2009-01-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

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• Z-2444-2012 — SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.Class II·Terminated·RAYSEARCH LABORATORIES AB·20111010
• Z-2378-2012 — The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetristsClass II·Terminated·RAYSEARCH LABORATORIES AB·20110530

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083264.