TELEFLEX INCORPORATED ASK-29903-MHI ARROW

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and Multi-Media medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images from a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data with access to clinical reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians, clinicians and other medical professionals. The Vitrea View software is scalable due to the web-based zero-footprint architecture which allows sites to quickly and easily add new users as demand grows. The software may also be deployed in a virtualized environment.