Data / Medical devices / India / Philips India Limited - Magnetic Resonance Business Unit
Philips India Limited - Magnetic Resonance Business Unit: FDA-registered device maker in Bengaluru Karnataka, India, 30 510(k) clearances
Philips India Limited - Magnetic Resonance Business Unit is registered with the FDA (registration 3033527281) in Bengaluru Karnataka, India. It lists 4 device types. The FDA files 30 510(k) clearances under its listings, the newest dated February 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033527281
- Address
- Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka, Bengaluru Karnataka, India, 560064
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 12, 2008
- Registered through
- 2026
- Brand names listed
- ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x, Achieva, Achieva 1.5T family, Achieva 1.5T, 3T, and Intera 1.5T, Achieva Family, Achieva R4 1.5T (Ingenia), Achieva R4 3T (ingenia), Achieva, Intera,&Panaroma 1T R2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 23, 2026 | K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 4, 2025 | K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 2, 2023 | K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 28, 2023 | K230972 | Ingenia Elition and MR 7700 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 6, 2023 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 23, 2022 | K223442 | MR 5300 and MR 7700 R11 MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| April 5, 2022 | K214081 | MRCAT Head & Neck | MUJ | Substantially Equivalent | Philips OY | accessdata.fda.gov |
| March 3, 2022 | K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| November 19, 2021 | K212673 | MR 5300 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 10, 2020 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 24, 2020 | K193109 | MRCAT brain | MUJ | Substantially Equivalent | Philips Medical Systems MR Finland | accessdata.fda.gov |
| June 4, 2019 | K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 30, 2019 | K182888 | MRCAT Pelvis | MUJ | Substantially Equivalent | Philips Medical Systems MR Finland | accessdata.fda.gov |
| February 14, 2019 | K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 3, 2018 | K181479 | Ingenia Ambition S and Ingenia Ambition X | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 4, 2018 | K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 20, 2018 | K173451 | Ingenia Elition S and Ingenia Elition X | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 6, 2018 | K173356 | Ingenia Elition S and Ingenia Elition X R5.4 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 6, 2017 | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 6, 2017 | K162931 | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 22, 2016 | K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | LNH | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| February 25, 2016 | K151435 | MRCAT | MUJ | Substantially Equivalent | Philips Medical Systems MR Finland | accessdata.fda.gov |
| March 22, 2011 | K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T | LNH | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| January 4, 2007 | K063559 | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 | LNH | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 7, 2005 | K052078 | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 2, 2005 | K052013 | ACHIEVA 1.5T & INERA 1.5T FAMILY | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| February 15, 2005 | K043147 | ACHIEVA FAMILY | LNH | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| July 26, 2004 | K041602 | PANORAMA 1.0T | LNH | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| September 10, 2003 | K031815 | INTERA-SENSATION FAMILY | LNH | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| December 11, 2001 | K013344 | INTERA I/T | LNH | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Set, I.V. Fluid Transfer
Updated February 23, 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.