RayStation— 510(k) K160093

Clearance details

Applicant

RaySearch Laboratories AB (PUBL)

Product code

Code MUJ

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2016-01-19

Decision date

2016-04-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

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• Z-1194-2025 — Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250116
• Z-1815-2017 — Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needsClass II·Terminated·RAYSEARCH LABORATORIES AB·20170118
• Z-0721-2017 — RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.Class II·Terminated·RAYSEARCH LABORATORIES AB·20161109
• Z-0720-2017 — Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.Class II·Terminated·RAYSEARCH LABORATORIES AB·20161011
• Z-0038-2017 — RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.Class II·Terminated·RAYSEARCH LABORATORIES AB·20160901
• Z-2206-2016 — RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.Class II·Terminated·RAYSEARCH LABORATORIES AB·20160701
• Z-0079-2017 — Radiation Therapy Treatment Planning System, Model 5.0Class II·Terminated·RAYSEARCH LABORATORIES AB·20160530

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160093.