FDA clears Siemens IV-MRI package

Article

Siemens Medical Systems has received 510(k) marketing clearancefor an upgrade package for its Magnetom Open MRI scanner thatenables clinicians to perform MRI-guided procedures with the scanner.The FDA's move also allows the Iselin, NJ, vendor to promote

Siemens Medical Systems has received 510(k) marketing clearancefor an upgrade package for its Magnetom Open MRI scanner thatenables clinicians to perform MRI-guided procedures with the scanner.The FDA's move also allows the Iselin, NJ, vendor to promote theuse of Open for interventional imaging, which was not includedin Open's original 510(k) clearance document (SCAN 4/6/94).

Siemens' MR-Guided Procedures Package includes hardware suchas a bore light, ergonomic chair, foot pedal to initiate scans,multipurpose 35-cm coil, auto-display of images as they are acquired,and an optional in-room monitor. It also includes fast imagingsequences, according to Anne Deery Sheehan, Open product manager.

The package was designed to allow clinicians to conduct MR-guidedbiopsies and drainages on a range of anatomyfrom the head andneck to the spine, abdomen, and extremities. The package has beenunder evaluation at University Hospitals of Cleveland and at sevensites in Europe.

Siemens believes that the option is the first clinically availableMR-guided surgery package. Siemens will offer the package as anoption for installed Open scanners, with a list price of $155,000including in-room monitor. A new Open with the package will probablylist for around $1 million.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
Can Radioligand Therapy Have an Impact for Women with Breast Cancer?
Emerging Concepts in CT-Guided Treatment of Coronary Artery Disease
SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Related Content
© 2025 MJH Life Sciences

All rights reserved.