53 results
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Sources: EU EUDAMED, US FDA
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RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·May 1, 2019
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
FDA Enforcement
Class II
·Terminated·Brainlab AG·June 15, 2016
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
FDA Enforcement
Class II
·Terminated·Brainlab AG·November 11, 2015
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
FDA Enforcement
Class II
·Terminated·Brainlab AG·March 21, 2018
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
FDA Enforcement
Class II
·Terminated·Brainlab AG·September 2, 2015
Doc Cirrus GmbH
Manufacturer
🇩🇪 Germany
Stemi 508 doc
Device
EU IVDR
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Eu Ivd Class A
·Carl Zeiss Microscopy GmbH·No longer on the market·32 countries
RIMPulse Android Watch application
Device
EU MDD
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Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse firmware
Device
EU MDD
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Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse PC Application
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse Apple Watch application
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse iOS Mobile application
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse Android Mobile Application
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse Mobile ECG Device and System
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse Mobile ECG Device and System
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
RIMPulse Server Software
Device
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·On the market·1 country
Occipital plate, sterile, midline, for OC rod, with 2 OC locking screws
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·ulrich GmbH & Co. KG·2 devices
RIMPulse Android Watch application
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Pulse for Integrated Solutions GmbH·1 device