Grapefruit USA Inc (GPFT)

[BennyJ]

Radiologist review report is the performance data -> Expect the news of SE of soon...

http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm080252.gif

In the above flow chart we are at number 10

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050996.pdf

Intended Use is going to be similar to like this:

-Replace the O-Arm to Dominion DVIS
-Replace the 3D imaging to 3D real-time Fluoroscopic
-Add 16 slice CT scan(plenty out there in the market already) - Added funcationaliy for DVIS

Intended Use
The O-ArmnTM Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-ArmTm Imaging System is compatible with certain Image Guided Surgery Systems.

Similarities and comparison section will be similar to one described in the document(second link above - 2nd link)

Performance data is going to similar to one what they listed in the 510k in the document.(second link above - 2nd link)
(2 Radiologists review comparing the images in different modalities
2D, 3D and CT. )
we all know safety doesn't matter at all( we are far better than industry standard - 50% less to at the max equal to the industry standard)
if the reviewer OK with radiologist review, we will get approval(effectiveness part of it)

IMGG is going to be approved pretty soon.