( Picture Archiving and Communication System ) FDA 510K #K072637

1. (Picture Archiving and Communication System)FDA 510K #K072637 Introduction to

2. Picture Archiving and Communication Systems (PACS) are computers and other computerized hardware which run software programs dedicated to the storage, retrieval, distribution and presentation of medical diagnostic images, video and data. Data Storage Internet Modem Imaging Modality Review Workstation Remote Access

3. A Picture Archiving and Communications System consists of four major hardware components: the imaging modality such as Ultrasound, MRI, CT, etc. a secure network for the transmission of the information, archives for long and short term storage and retrieval of images and reports. workstations for interpreting and reviewing images.

4. PACS Software PACS software falls into 4 major categories • Software which creates the images and data • Software which stores the images and data • Software which transports the images and data • Software which displays the images and data

5. PACS Architecture DIVO consists of a laptop computer, mounted onto an ultrasound machine or imaging device and a network attached storage box which stores and distributes the images, movies and reports, either locally or remotely, in a secure HIPAA compliant manner.

6. WHY DIVO? Beside the fact that DIVO can be added to any imaging system, old or new, DIVO creates and enables electronic images and movies about 1/100 the size of dicom files. This enables them to be archived, accessed and transmitted easily and quickly, eliminating the need for cds and couriers. Traditional dicom has worked well for radiologic images for many years but still falls far short when it comes to echo and other motion studies.

7. Because DIVO is a laptop it can… • Access previous studies right at the imaging device: • DIVO can electronically access previous studies and play them directly at the imaging device. • Access studies remotely: DIVO, unlike conventional Echo PACS systems, provides rapid off-site access over the internet. It enables practitioners in different physical locations to access the same information simultaneously and it is able to provide doppler audio, triplex, and longer videos than dicom can. • Access networked software: DIVO provides the electronic platform for accessing other medical automation systems such as Hospital Information Systems (HIS), Electronic Medical Records Systems (EMR) and Radiology Information Systems (RIS) at the imaging station. It can make CDs and DVDs there too. • Access the internet: DIVO can provide access to email, educational materials and other internet resources, from the imaging device.

8. Divo File Format MULTIMEDIA is the standard DIVO uses for handling, storing, printing, and transmitting information using all possible media and transport methods, including DICOM. Multimedia is not specific to medical imaging. • Multimedia includes numerous file format definitions and networkcommunications protocols to enable communication between systems. Multimedia files can be exchanged between two entities that are capable of receiving image and patient data in a variety of formats. The multimedia standard includes both media (data storage and transmission) and content (information) that use a wide variety of different software programs. • Multimedia includes a combination of text, audio, still images, animation and video, using content forms which may also include DICOM. • Multimedia content can be recorded and played, displayed or accessed by information processing software on devices such as computers, DVD players and computerized devices like cell phones or ultrasound machines. • The communication protocols used for multimedia files can be any HIPAA compliant method including but not limited to SFTP (secure file transfer protocol), VPN (virtual private networking) with TCP/IPTransmission Control Protocol(TCP) and the Internet Protocol(IP).

9. DIVO Imaging devices • DIVO Multimedia static and motion video capture/networking can be added to any imaging device, no matter how old or how new.

10. DIVO Image Viewer • Divo studies can be viewed on PCs or Macs and have various tools like zoom, brightness and contrast, scrolling video, pause, double screen to view two or more movies at once, thumbnails, and can view pdf, docs, scanned in files etc

11. CONVENTIONAL DICOM PACS DISADVANTAGES Video clip 3 sec • DICOM image files are very large, making remote access more time consuming and jerky, especially with video. • DICOM files have no doppler audio. • DICOM files have no triplex, scrolling M or doppler modes. • DICOM video files have very limited duration. • DICOM files require application specific software for viewing. • DICOM cannot incorporate standard computing programs like word, adobe and others or standard computing hardware like scanners and printers. Video clip 3 sec Video clip 3 sec Video clip 3 sec Video clip 3 sec

12. DIVO PACS Advantages • Smaller file sizes transport much faster. • Unlimited video lengths. • Audio, triplex, scrolling doppler and m mode • Paper, PDF, DOC, TXT etc can be scanned into patient file. • Instant retrieval of archived studies from LAN or WAN. • Can be added to legacy equipment which cannot upgrade to DICOM. • Can be viewed on any computer Mac or PC Video clip 3 sec Video clip 30 sec Video clip 3 minutes Video clip 30 minutes

13. Installed base • Since 2005 Divo has been installed in over 180 locations including Guam, Holland, Israel, Dubai and all over the USA.

14. A2D Imaging LLC 17271 Lido Lane Huntington Beach, Ca 92647 818 324 2871 www.a2dimaging.com