Philips India Limited

FDA Device Registration & Listing · Pune Maharashtra, IN · Registration 3010685285

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010685285
FEI Number
3010685285
Entity Name
Philips India Limited
City/State/Country
Pune Maharashtra, IN
Establishment Address
Plot no. B-79, MIDC, Phase-II, Chakan, Taluka - khed, Village - Savardari, Pune Maharashtra 410 501, IN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Zenition 70 StentBoost Mobile Zenition 30 BV Pulsera BV Endura Veradius Unity Zenition 50 Zenition 90

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 2019-03-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2019-03-27
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2019-03-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2021-04-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-02-20
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-02-20
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-02-20
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2006-02-21
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2006-02-21
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2006-02-21
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2014-10-31
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2014-10-31
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2014-10-31
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2019-03-27
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2019-03-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2019-03-27
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-05-24
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-05-24
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: Philips 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;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010685285. Last updated year: 2026. Please use registration number 3010685285 when referencing this establishment in official correspondence.
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