Company:Toshiba American Medical Systems Inc. Date of Enforcement Report 3/21/12 Class ll: PRODUCT 1) TSX-301A: AQUILION ONE; System, X-Ray, Tomography. Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism...Read More

Company:Clarity Medical Systems Inc. Date of Enforcement Report 3/21/12 Class ll: PRODUCT Retcam3 & Retcam Shuttle with version 6.0 software. General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. Model number RC3, part number...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 3/21/12 Class ll: PRODUCT Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes...Read More