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Philips India Limited - Image Guided Therapy Systems Business Unit: FDA-registered device maker in Pune Maharashtra, India, 9 510(k) clearances

Name: Philips India Limited - Image Guided Therapy Systems Business Unit FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips India Limited - Image Guided Therapy Systems Business Unit is registered with the FDA (registration 3033525987) in Pune Maharashtra, India. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 7, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033525987
Address: Devi ICC Gaurav Tech Park Old Mumbai-Pune Highway Pimpri 1st Floor, Pune Maharashtra, India, 411018
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Specification developer
First device listed: February 21, 2006
Registered through: 2026
Brand names listed: BV Endura, BV Pulsera, StentBoost Mobile, Veradius Unity, Zenition 30, Zenition 50, Zenition 70, Zenition 90

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Specification developer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 7, 2026	K254205	Zenition 30	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 22, 2024	K240224	Zenition 90	OWB	Substantially Equivalent	Philips Medical Systems Nederlands B.V.	accessdata.fda.gov
February 16, 2024	K232420	Zenition 30	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
October 1, 2021	K212813	Zenition 70	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
April 5, 2021	K203623	StentBoost Mobile	OWB	Substantially Equivalent	Philips India Limited	accessdata.fda.gov
December 31, 2018	K183101	Zenition 50	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
December 6, 2018	K183040	Zenition 70	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
October 22, 2014	K142708	VERADIUS UNITY	OWB	Substantially Equivalent	Philips Medical Systems Nethrlands BV	accessdata.fda.gov
March 12, 2001	K010435	PHILIPS BV PULSERA/ENDURA	OWB	Substantially Equivalent	Philips Medical Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.