Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033527770

FEI Number

3033527770

Entity Name

Philips India Limited - Diagnostic X-ray 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

K964124

PMA Number

N/A

All Registered Proprietary Names

ProxiDiagnost N90 Precision CRF DigitalDiagnost C90 CombiDiagnost R90 DigitalDiagnost C90 DigitalDiagnost ProGrade SkyPlate CombiDiagnost R90 CombiDiagnost R90 DuoDiagnost Radiography 7300 C Film and Accessories EasyDiagnost Eleva ProxiDiagnost N90 DigitalDiagnost Radiography 7000 M SkyFlow SkyFlow ProxiDiagnost N90 / Precision CRF PCR Eleva S Plus PCR Eleva Corado PCR Eleva S HI Res PCR Eleva S PCR Cosima X Eleva

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-10-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-01-22
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-01-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-01-22
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-11-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-11-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-10-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-10-05
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2020-10-05
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-07-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-07-29
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-01-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2021-01-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-01-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2017-02-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-02-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-02-10
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2001-06-04
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2001-06-04
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-06-20
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-06-20
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2007-11-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2007-11-21
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2007-11-21
IXL	Device, Spot-Film	Radiology	Class 2	892.1670	2007-11-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-02-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-02-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-05-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-05-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2021-05-25
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2024-02-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-02-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-02-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-05-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-05-12
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-01-17
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-01-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2001-05-31

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
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
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

Similar Registrations

Registration Number	Establishment Name	Location
1000221974	DMX IMAGING, LLC	Palm Harbor, FL, US
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033527770. Last updated year: 2026. Please use registration number 3033527770 when referencing this establishment in official correspondence.