Medical Device Manufacturer · US , Carmel , IN

Giotto USA, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2006

Recent clearances: BIOPSY DIGIT S BIOPSY SL, GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L, BIOPSY DIGIT-AM

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Giotto USA, LLC Radiology ✕

3 devices

1-3 of 3

Cleared Aug 10, 2012

BIOPSY DIGIT S BIOPSY SL

Radiology · 248d

Cleared Oct 27, 2011

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L

Radiology · 157d

Cleared Sep 11, 2006

BIOPSY DIGIT-AM

Radiology · 54d