Philips India Limited - Image Guided Therapy Systems Business Unit

FDA Device Registration & Listing · Pune Maharashtra, IN · Registration 3033525987

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
3033525987
FEI Number
3033525987
Entity Name
Philips India Limited - Image Guided Therapy Systems Business Unit
City/State/Country
Pune Maharashtra, IN
Establishment Address
Devi ICC Gaurav Tech Park Old Mumbai-Pune Highway Pimpri, 1st Floor, Pune 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
N
Expiration Date (Year)
2026
510(k) Number
K142708
PMA Number
N/A

All Registered Proprietary Names

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

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 2021-10-15
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2021-10-15
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2021-10-15
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
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
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
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
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
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

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
K060344 Breakaway Imaging, LLC O-ARM IMAGING SYSTEM 2006-03-29
K982706 Philips Medical Systems, Inc. PHILIPS BV300 SERIES RELEASE 2.1 1998-09-02
K863853 Superior Medical Products EAZY COVERS 1987-03-06
K953974 Medivision Medical Imaging, Ltd. CAMVISION 1000 1996-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0357-2022 Philips North America Llc 2
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
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;

Similar Registrations

Registration Number Establishment Name Location
3021027284 ANGIOWAVE IMAGING, INC. Concord, MA, 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 3033525987. Last updated year: 2026. Please use registration number 3033525987 when referencing this establishment in official correspondence.
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