xx.xxIntelliSpace Radiology
Philips Healthcare Informatics, Inc.
Philips Healthcare Informatics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2954704 | 3002971142 | Philips Healthcare Informatics, Inc. | 1 | Y | 2020-04-25 | 4430 Rosewood Drive, Suite 200 Pleasanton CA US 94588 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00884838074781 | IntelliSpace PACS - IntelliSpace PACS is an image management system 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. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. | +1(800)722-9377 | xx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 96364 | 1434297284 | K182926 | IntelliSpace Radiology | LLZ | 2018-12-06 |
| 96364 | 1363211749 | K111804 | INTELLISPACE PACS 4.X | LLZ | 2011-07-28 |
| 96364 | 1471052746 | K072960 | CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET | LLZ | 2007-11-08 |
| 96364 | 1634770293 | K063267 | ISITE PACS, V 4. X | LLZ | 2006-11-09 |
| 96364 | 1398944046 | K042292 | ISITE PACS | LLZ | 2004-09-08 |
| 96364 | 1370910182 | K032096 | PHILIPS VIEWFORUM 2003 | LLZ | 2003-07-18 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 6 | 2018-12-06 |
PMN#
INTELLISPACE PACS 4.X
PHILIPS HEALTHCARE INFORMATICS, INC.
GUDID#
IntelliSpace PACS - IntelliSpace PACS is an image management system 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. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
2016-09-24
IntelliSpace Radiology - IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.
2019-03-01
IntelliSpace Clinical Applications - "Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of ""off-the-shelf"" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images."
2018-09-30