Philips Healthcare Informatics, Inc.

All units of these IntelliSpace PACS.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and country: Canada.

Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA || IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

Versions 4.1.x up to and including 4.1.51.3

Radiology Devices

2

No

International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.

iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. || Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage

Software versions 3.6.28.x and 4.1.x.

Radiology Devices

2

No

Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.

iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. || The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.

all products with software versions 3.5.x

Radiology Devices

2

No

Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria

Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x || The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.

Version 4.1.17.0

Radiology Devices

2

No

Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.

Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.