Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033525986

FEI Number

3033525986

Entity Name

Philips India Limited - Diagnostic X-ray Business Unit

City/State/Country

Pimpri Maharashtra, IN

Establishment Address

Devi ICC Gaurav Tech Park Old Mumbai-Pune Road, Pimpri-Waghere, Ground Floor,, Pimpri Maharashtra 411018, 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

CombiDiagnost R90 Radiography 7300 C ProxiDiagnost N90 / Precision CRF CombiDiagnost R90 DigitalDiagnost ProxiDiagnost N90 DigitalDiagnost ProGrade SkyPlate ProxiDiagnost N90 Precision CRF CombiDiagnost R90 DigitalDiagnost C90 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
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
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
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
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
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
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
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
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	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
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2001-05-31

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling 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
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21
K123106	Samsung Electronics Co., Ltd.	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20
K203340	Siemens Medical Solutions USA, Inc.	MULTIX Impact C	2021-01-06
K230241	Sg Healthcare Co, Ltd.	Jumong General	2023-02-23
K863853	Superior Medical Products	EAZY COVERS	1987-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015	Siemens Medical Solutions USA, Inc	2	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
Z-0003-2015	Siemens Medical Solutions USA, Inc	2	Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Z-0004-2015	Siemens Medical Solutions USA, Inc	2	Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033525986. Last updated year: 2026. Please use registration number 3033525986 when referencing this establishment in official correspondence.