Company: Hologic, Inc., Date of Enforcement Report 10/15/2008 Class:ll PRODUCT a) Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment,...Read More

Company: Abbott Laboratories Date of Enforcement Report 10/15/2008 Class:ll PRODUCT ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity, Recall...Read More

Company: VISX Inc., a Subsidiary of AMO, Inc. Date of Enforcement Report 10/15/2008 Class:ll PRODUCT AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/15/2008 Class:ll PRODUCT Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential...Read More