Company:Vital Images, Inc. Date of Enforcement Report 2/22/12 Class ll: PRODUCT Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images...Read More

Company:Spacelabs Healthcare, LLC Date of Enforcement Report 2/22/12 Class ll: PRODUCT Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/22/12 Class ll: PRODUCT Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326). Intended to produce cross-sectional images of the body by comcomputer...Read More

Company:Leica Microsystems, Inc. Date of Enforcement Report 2/22/12 Class ll: PRODUCT Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201. The intended use of the microscope is for...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/22/12 Class ll: PRODUCT ) Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...Read More