38 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
FDA 510(k)
FDA Class 2
·Radiology
9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
NA
FDA UDI
Smith & Nephew, Inc.·03596010025142·FIXATION BUTTON 17MM (BOX 6)
UNBRANDED
FDA UDI
ADVANCE MEDICAL DESIGNS, INC.·00848340000263·Snap Kover
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008636·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008490·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00193033532157·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00193033532119·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008520·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008506·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008469·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008629·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008537·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008605·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00193033532089·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00193033532072·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008513·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00193033532096·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00193033532133·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304008483·