Data / Medical devices / India / Philips Global Business Services LLP
Philips Global Business Services LLP: FDA-registered device maker in Pune Maharashtra, India, 62 510(k) clearances
Philips Global Business Services LLP is registered with the FDA (registration 3016851825) in Pune Maharashtra, India. It lists 5 device types. The FDA files 62 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016851825
- Address
- B-78/B-79, MIDC Chakan Industrial area Phase 2, Pune Maharashtra, India, 410501
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 19, 1992
- Registered through
- 2026
- Brand names listed
- 0.6T Marconi Wrist and Hand Array, 0.6T Panorama 4Ch Breast Array, 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil, 1.5T 16CH Cardiac Coil- Anterior, 1.5T 16CH Cardiac Coil- Posterior, 1.5T 16Ch GE Shoulder Coil, 1.5T 32CH Cardiac Coil- Anterior, 1.5T 32Ch Cardiac Coil- Anterior and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Breast Biopsy / Localization Tray | PXP | 1 | Specification developer | accessdata.fda.gov |
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 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 |
|---|---|---|---|---|---|---|
| July 30, 2026 | K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 24, 2026 | K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 14, 2026 | K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 18, 2024 | K243033 | dS Wrist coil 8ch 1.5T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 18, 2024 | K242879 | dS Knee Coil 8ch 1.5T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 12, 2024 | K242096 | dS FootAnkle Coil 8ch 1.5T | MOS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 24, 2023 | K233348 | 16 Breast Coil | MOS | Substantially Equivalent | Philips Medical System Nederlands B.V. | accessdata.fda.gov |
| October 3, 2023 | K232762 | dS Breast Coil 7ch 1.5T | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| August 31, 2022 | K222325 | 8ch Wrist Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| August 23, 2022 | K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| August 8, 2022 | K213735 | dS Sentinelle Breast 16ch 1.5T Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| August 8, 2022 | K213727 | dS Sentinelle Breast 16ch 3.0T Coil | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| December 23, 2021 | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| October 29, 2021 | K213351 | ds Head 32ch 3.0T | MOS | Substantially Equivalent | Invivo Corporation (Business Trade Name: Philips) | accessdata.fda.gov |
| November 7, 2016 | K162863 | dS Small Extremity 16CH 1.5T Coil | MOS | Substantially Equivalent | Invivo Therapeutics Corporation | accessdata.fda.gov |
| September 14, 2016 | K162177 | dS FootAnkle I6CH 1.5T Coil | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| August 31, 2016 | K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| December 21, 2012 | K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| December 13, 2012 | K123492 | DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) | MOS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| November 2, 2012 | K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| August 25, 2011 | K112112 | SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS | MOS | Substantially Equivalent | Sentinel Medical, Inc. | 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 |
| April 22, 2010 | K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 | MOS | Substantially Equivalent | Sentinelle Medical, Inc. | accessdata.fda.gov |
| March 5, 2010 | K093842 | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| August 21, 2009 | K091902 | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| November 6, 2008 | K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| October 15, 2008 | K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| November 16, 2007 | K072873 | LBS-63-16 BREAST ARRAY COIL | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| October 13, 2006 | K062767 | CTL-63 AND CTL-128 SPINE ARRAY COILS | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| July 28, 2006 | K061952 | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 | MOS | Substantially Equivalent | Invivo | accessdata.fda.gov |
| April 14, 2006 | K060873 | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS | MOS | Substantially Equivalent | Sentinelle Medical, Inc. | accessdata.fda.gov |
| November 16, 2005 | K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS | MOS | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| October 12, 2005 | K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A | MOS | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
| April 8, 2005 | K050622 | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| April 7, 2005 | K050621 | NVA-127-8-A NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| March 25, 2005 | K050514 | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| February 24, 2005 | K050299 | HRK-123 KNEE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| August 16, 2004 | K042103 | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corporation | accessdata.fda.gov |
| July 19, 2004 | K041481 | MODEL BBC-127 BIOPSY BREAST COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 5, 2004 | K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| November 25, 2003 | K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| October 23, 2003 | K032576 | BIOPSY BREAST COIL, MODEL BBC | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| September 25, 2003 | K032633 | HRK-63-8 KNEE ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| August 21, 2003 | K032429 | QSC-127 SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| January 9, 2003 | K024352 | HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| January 9, 2003 | K024209 | QWH-250-PAN WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| January 7, 2003 | K024208 | OBC-250-PAN BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| December 16, 2002 | K023084 | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL | MOS | Substantially Equivalent | Medical Advances, Inc. | accessdata.fda.gov |
| September 4, 2002 | K022588 | HRW-63-INT WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| August 23, 2002 | K022488 | MODEL OBC-63 BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| August 13, 2002 | K022372 | HRH-127-8 HEAD ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| June 12, 2002 | K021575 | OBC-127 BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 13, 2002 | K020606 | NVA-63-8 NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| October 16, 2001 | K013159 | HRH-63-8 HEAD ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| December 3, 1999 | K993776 | OBC-300 BREAST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| November 1, 1999 | K993477 | HRW WRIST ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| June 6, 1997 | K970868 | MODEL HNC NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| September 5, 1996 | K961525 | ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) | MOS | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| July 3, 1996 | K961366 | MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS | LNH | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
| March 23, 1995 | K945778 | PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL | LNH | Substantially Equivalent | Medical Advances, Inc. | accessdata.fda.gov |
| June 8, 1994 | K941025 | PHASED ARRAY BREAST COIL | LNH | Substantially Equivalent | Medical Advances, Inc. | accessdata.fda.gov |
| November 24, 1993 | K934396 | QUADRATURE LOWER EXTREMITY COIL | LNH | Substantially Equivalent | Medical Advances, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Needle, Surgical
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Breast Biopsy / Localization Tray
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
Updated July 30, 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.