Philips Healthcare Informatics Inc

FDA Filings

This page includes the latest FDA filings for Philips Healthcare Informatics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2954704
• FEI Number: 3002971142
• Name: Philips Healthcare Informatics, Inc.
• Owner & Operator: Philips Medical Systems International BV
• Contact Address: Tussendiepen 4 ; Drachten NL-NOTA 9206 AD NL
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4430 Rosewood Drive, Suite 200 ; Pleasanton, CA 94588 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00884838091740 Philips Healthcare Informatics, Inc.	IntelliSpace Radiology 836344	2019-03-11
GUDID 00884838074781 Philips Healthcare Informatics, Inc.	IntelliSpace PACS 837507	2019-02-05
PMN K182926 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	IntelliSpace Radiology	2019-01-10
PMN K182926 Philips Healthcare Informatics, Inc.	IntelliSpace Radiology	2018-12-06
GUDID 00884838091849 Philips Healthcare Informatics, Inc.	IntelliSpace Clinical Applications 837509	2018-10-31
PMN K111804 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	IntelliSpace PACS 4.X	2011-08-09
PMN K111804 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	IntelliSpace Breast	2011-08-09
PMN K111804 PHILIPS HEALTHCARE INFORMATICS, INC.	INTELLISPACE PACS 4.X	2011-07-28
PMN K032096 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	ViewForum	2009-09-03
PMN K032096 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	ViewForum - iSite	2009-09-03
PMN K032096 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	ViewForum - Xcelera MR/CT Viewer	2009-09-03
PMN K032096 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	Multi-modality Breast Applications	2009-09-03
PMN K032096 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	IntelliSpace Clinical Applications	2009-09-03
PMN K032096 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	IntelliSpace Clinical Applications 8.2	2009-09-03
PMN K072960 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	MDC PACS	2009-08-11
PMN K063267 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	ISITE PACs V4.X	2008-12-01
PMN K042292 | LLZ Philips Healthcare Informatics, Inc. [Philips Medical Systems International BV]	ISITE PACs	2008-12-01

Related Finance Registrations

CAGE Code	3LJJ9	PHILIPS HEALTHCARE INFORMATICS, INC. PHILIPS HEALTHCARE INFORMATICS
S.A.M. Registration	3LJJ9 [95471327]	PHILIPS HEALTHCARE INFORMATICS, INC.