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510k Database
Manufacturers
US
Giotto USA, LLC
Medical Device Manufacturer
·
US , Carmel , IN
Giotto USA, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Giotto USA, LLC
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607
·
IZH
Radiology
·
248d
Cleared
Oct 27, 2011
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
K111434
·
MUE
Radiology
·
157d
Cleared
Sep 11, 2006
BIOPSY DIGIT-AM
K062039
·
IZH
Radiology
·
54d
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Radiology
3