FDA 510(k) indications for use

 

 

 

 

 

 

 

 

 

 

 

 

 

 

510(k) Numbers: K925994, K925929, K943994

FDA owner/operator number: 9052954

USA FDA Regulatory Clearance and Indications For Use:

 

 

 

 

The OpenMed Software, when installed on an appropriate hardware platform, is intended to provide capability for the collection, display, optional compression, storage, workflow management and/or digital processing of clinical images, digitized waveforms, text or clinical information.

The communication of information is across local or wide area networks including public communication channels. The capture is directly from different medical image or data collection modalities through digital interfaces or through digitization of images or documents from film, paper, software interfaces or photographic or video sources. OpenMed Software integrates all sources of patient data and multimedia into the patient folder, combining demographic, clinical and multimedia information.

OpenMed Software is indicated for use by health care professionals or providers whenever there is a need to review, store or access a patient record and/or any part of the information stored therein.