Grapefruit USA Inc (GPFT)

[wallstreetgenuis]

kimble1, PMA route paranoia is non-sense.
Here are proofs that equivalent equipments were submitted to FDA using 510k route and were approved. Read the description of these machine on the links provided below, they are almost exactly the same with DVIS
1)First:
Manufacturer:Breakaway Imaging LLC
Product Name: O-Arm Imaging System
Distributor:Medtronic
Link to FDA 510K:
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050996.pdf

Link to machine in Action: http://www.neurocirugia.com/instrumental/index.php?entry=entry071029-121953

2)Second:The above O-Arm Imaging System was approved because it is substantially equivalent to Siemens SireMobil Iso-C 3D,which is a C-Arm fluroscopy imaging system.
Link to FDA 510K: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040347.pdf
Link to machine in Action: http://www.medical.siemens.com/siemens/zh_CN/gg_spms_FBAs/files/brochures/siremobil_isoc_3d_broch_e.pdf

A couple of C-Arm fluoroscopy imaging machines from GE,Philips,Ziehm,Toshiba are substantially equivalent to DVIS because
DVIS is using the same x-ray unit components that are FDA approved and that are being used in most commercially available C-Arm fluoroscopy imaging machine.
The only difference between the C-Arm and O-Arm imaging system is the available angle of position to take a shot on the patient. 360 degrees versus 180 degrees.