Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033527282

FEI Number

3033527282

Entity Name

Philips India Limited - Image Guided Therapy Systems Business Unit

City/State/Country

Bengaluru Karnataka, IN

Establishment Address

Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka, Bengaluru Karnataka 560064, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160455

PMA Number

N/A

All Registered Proprietary Names

Azurion 7 B20 Azurion 5 M12 Azurion 3 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 M20 Azurion 5 M20 Azurion 7 B12 Azurion 7 M20 Azurion 3 M12 Azurion 7 B20 Azurion 5 M20 Azurion 5 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 B12 MR-CT Roadmap Rel. 1 Allura 3D-RA Rel. 6 3D Roadmap Rel. 1 3D-RA ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Dynamic Coronary Roadmap 2 Allura Xper FD series and Allura Xper OR Table series Interventional Workspot Allura 3D-CA 3D-CA CT TrueView Azurion 7 B12 Azurion 3 M15 Azurion 5 M12 Azurion 7 M12 Azurion 3 M12 Azurion 7 B20 Azurion 5 M20 Azurion 7 M20 EmboGuide R1 XperGuide StentBoost Live Heart Navigator Release 2 AneurysmFlow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-05-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-05-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2026-02-05
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-02-05
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-11-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-11-02
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-12-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-11-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2006-02-21
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2006-02-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-11-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-11-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-03-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-03-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-06-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-06-26
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-02-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV Email: maria.heiling@philips.com Phone: (858) 2487651

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

Registration Number	Establishment Name	Location
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3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3012631246	MEDPHOTON GMBH	Salzburg, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033527282. Last updated year: 2026. Please use registration number 3033527282 when referencing this establishment in official correspondence.