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Tuesday, August 03, 2010 12:40:58 AM
Proprietary Name: O-ArmTM Imaging System
Classification Names: Mobile X-ray System, Solid-state X-ray Imager
Classification Panel: Radiology
CER Sections: 21 CFR 892.1720, 21 CER 892.1650
Class: 11
Product Codes: IZL, MQB
None of the above which have been already approved in o-arm imaging(volumetric x-ray imaging) is REAL TIME, 3D & HIGH RESOLUTION Fluroscopy images. There is where IMGG stands out from the rest of the competitors. And it included mobile CT too. Half the cost from the rest of the competitors and Mobility is another advantages to move quickly to the ICU, operating theatres and ER.
But IMGG - closest product code - look at 10k filed April 2010. Dean has clearly explained what is the closest product matching and subproduct codes are.
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