FDA Registration Active 🇮🇳 India

Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units

Reg #: 3033527273 · FEI: 3033527273 · Expires 2026
Products
2
Proprietary Names
20
Establishment Types
3
Classifications
2

Registration Details

Registration Name
Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units
Registration Number
3033527273
FEI Number
3033527273
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
City
Bengaluru Karnataka
Country
IN

Regulatory Submissions

510(k) Number
K032096

Owner / Operator

Firm Name
Philips Medical Systems International BV
Operator Number
1217116
Address
Veenpluis 6
City
Best
State
NL-NOTA
Postal Code
5684PC
Country
NL

US Agent

Business Name
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
Contact Name
Martin Pedroza
Address
9965 Federal Drive
City
Colorado Springs
State
CO
ZIP
80921
Country
US
Phone
440 2197243

Products

Device Name Product Code
System, Image Processing, Radiological LLZ
System, Digital Image Communications, Radiological LMD

Proprietary Names

IntelliSpace Clinical Applications 8.2 ViewForum IntelliSpace Clinical Applications IntelliSpace PACS Anywhere FetView OBGYN Cloud Reporting IntelliSpace Portal V12.x Advanced Visualization Workspace V15.X AV Viewer Vue Motion Vue PACS, Vue PACS (Diagnostic) Radiology Operations Command Center Console NM Suite V15.X VUE PACS Desktop Diagnostic Viewer Enterprise Viewer Web Diagnostic Viewer Image Management IntelliSpace Radiology Vue PACS Vue PACS (Diagnostic)

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility