đź“Š Evidence-Based Reference
mri planner
Spectronic Medical Ab
Summary: The MRI planner by Spectronic Medical Ab is a device used for planning MRI-guided procedures. It is primarily used in radiotherapy and surgical planning. Key evidence highlights its role in improving precision in tumor segmentation and surgical planning.
FDA Clearance Information
Pathway
510K
Number
K211841 ↗
Decision Date
August 25, 2022
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The MRI planner received FDA clearance through the 510(k) pathway on August 25, 2022. It is manufactured by Spectronic Medical Ab and classified as a Class 2 device.
What It Is
The MRI planner is a software tool designed to assist clinicians in planning MRI-guided procedures. It enhances the accuracy of imaging and segmentation, particularly in oncology settings.
Clinical Applications
Commonly used in radiotherapy and surgical planning, the MRI planner aids in precise tumor localization and treatment planning. It is particularly beneficial in head and neck, bladder, and rectal cancers.
Evidence Summary
The literature includes 12 studies, comprising RCTs, prospective, and retrospective studies, published between 2022 and 2025. These studies explore the device's efficacy in various clinical scenarios.
Reported Outcomes
Published studies report improved accuracy in tumor segmentation and surgical planning, particularly in head and neck and rectal cancers. The device enhances precision in MRI-guided procedures, contributing to better clinical outcomes.
Safety Profile
Reported complications include challenges in accurately segmenting tumor volumes, particularly in complex anatomical regions. However, no significant adverse events were noted in the studies reviewed.
Evidence Limitations
Evidence gaps include a need for larger, multicenter trials to validate findings across diverse populations. Some studies lacked detailed safety data, highlighting the need for comprehensive safety evaluations.
Frequently Asked Questions
What are the clinical indications for MRI planner?
The MRI planner is indicated for use in planning MRI-guided radiotherapy and surgical procedures, particularly in oncology.
What outcomes have been reported in clinical studies?
Studies report improved precision in tumor segmentation and surgical planning, leading to better treatment outcomes.
What complications have been reported?
Reported complications include challenges in tumor segmentation accuracy, but no significant adverse events were noted.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.