Do you know what the radiation output of the DVis is rated at? Also do you know that radiation levels drop off logarithmically at 6 feet? Portable Xrays are taken all the time in pt rooms, ER and ICU without lead walls or lead screens. Everybody is asked to move away and the tech throws on a lead vest because they are the closest. An announcement is made that an Xray is being made and to move away. All efforts are made to reduce exposure. If you are more than 6' away your exposure is minimal(not zero). I work in a Cath Lab every day and this information is from our Radiation exposure inservice. Personally I can't wait for the DVis to be approved and installed in our labs. I'll probably be retired before it happens. Why? Because I'll be paying of my mortgage from this stock and retiring to make wine.
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
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.
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