FDA clears Siemens IV-MRI package

July 3, 1996

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.