FDA.reportPublic FDA data

Philips Healthcare Informatics, Inc.

Matched from indexed company URL: PHILIPS HEALTHCARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29547043002971142Philips Healthcare Informatics, Inc.1Y2020-04-254430 Rosewood Drive, Suite 200 Pleasanton CA US 94588

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00884838064751DuraDiagnost - The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.+1(800)722-9377shawn.guo@philips.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
963641434297284K182926IntelliSpace RadiologyLLZ2018-12-06
963641363211749K111804INTELLISPACE PACS 4.XLLZ2011-07-28
963641471052746K072960CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNETLLZ2007-11-08
963641634770293K063267ISITE PACS, V 4. XLLZ2006-11-09
963641398944046K042292ISITE PACSLLZ2004-09-08
963641370910182K032096PHILIPS VIEWFORUM 2003LLZ2003-07-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ62018-12-06

PMN#

CT 5300

2024-05-03

Philips Healthcare (Suzhou) Co., Ltd.

Access CT

2019-07-29

Philips Healthcare (Suzhou) Co., Ltd.

45 records. Showing 1-40. Next

GUDID#

Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

2019-10-01

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."

Philips Healthcare Informatics, Inc.

2018-09-30

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.

Philips Healthcare Informatics, Inc.

2019-03-01

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.

Philips Healthcare Informatics, Inc.

2016-09-24