6 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Sweden
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S-FILE, S-FINDER, S-ENGINE FILE
FDA 510(k)
FDA Class 1
·Dental
ISO FILE, GENIE MEDICAL BAHS 2023.1 UK
Device
EU MDR
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Eu Md Class 2a
·Oticon Medical AB·On the market·15 countries
ISO FILE, GENIE MEDICAL BAHS 2024.2 UK
Device
EU MDR
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Eu Md Class 2a
·Oticon Medical AB·On the market·15 countries
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·September 2, 2020
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component
FDA Enforcement
Class II
·Ongoing·C-RAD POSITIONING AB·June 4, 2025
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.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·October 3, 2012