![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Friday, August 06, 2010 12:58:33 AM
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.
Simple Stock Loans Announces Unique Solutions For Investors Looking for Alternative Liquidity Amidst Recent Small Cap Rally Sep 6, 2024 9:30 AM
Reliant Coffee Debuts at #271 on the Inc. 5000 List of Fastest Growing Companies - Coffee Service Industry Disruptor Brews Up Exponential Growth Sep 5, 2024 11:51 AM
VAYK Confirms Receiving Revenue from First Airbnb Property with 1.4 Million Annual Revenue Goal • VAYK • Sep 4, 2024 9:34 AM
Mawson Finland Limited Expands Known Mineralized Zones at Rajapalot: New Lens Intercepts 21.75 m at 5.25 g/t Gold & 515 ppm Cobalt • MFL • Sep 4, 2024 9:02 AM
Integrated Ventures Acquires 51% Stake In GetTrim.Com (TM), Telemedicine Platform With Focus On Expansion Into Booming GLP-1 Powered Weight Loss Market • INTV • Sep 4, 2024 8:45 AM
Avant Technologies Announces Strategic Review Process Intended to Maximize Shareholder Value • AVAI • Sep 4, 2024 8:00 AM