FDA Registration
Active
🇮🇳 India
Philips India Limited - Ultrasound Business Unit
Reg #: 3033527283
·
FEI: 3033527283
·
Expires 2026
Products
7
Proprietary Names
208
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Philips India Limited - Ultrasound Business Unit
- Registration Number
- 3033527283
- FEI Number
- 3033527283
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
- City
- Bengaluru Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K162329
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2016-09-22 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2016-09-22 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2016-09-22 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-09-11 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2021-09-27 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2021-09-27 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2013-11-18 |
Proprietary Names
D5cwc
CX50 Diagnostic Ultrasound System
D2cwc
L12-5 50
C6-2
S8-3
S4-2
S7-3t
C10-3v
S5-1
C9-4v
L10-4lap
C8-5
L12-3
L12-4
C9-3io
C9-3v
X7-2t
L15-7io
Sparq Diagnostic Ultrasound System
C5-1
S12-4
CX50 Diamond Select Diagnostic Ultrasound System
Sparq Diamond Select Diagnostic Ultrasound System
CX50 Circular Edition Diagnostic Ultrasound System
Sparq Circular Edition Diagnostic Ultrasound System
Affiniti 70G Diagnostic Ultrasound System
V6-2
L18-5
C10-4ec
S8-3t
Affiniti 50C Diagnostic Ultrasound System
EPIQ 5C Diagnostic Ultrasound System
Affiniti 70W Diagnostic Ultrasound System
EPIQ 7G Diagnostic Ultrasound System
BP10-5ec
S9-2
X8-2ti
D2tcd
EPIQ 5 Diagnostic Ultrasound System
eL18-4
EPIQ 5W Diagnostic Ultrasound System
VL13-5
Affiniti 50G Diagnostic Ultrasound System
X5-1
EPIQ CVx Diagnostic Ultrasound System
Affiniti 50W Diagnostic Ultrasound System
3D9-3v
X8-2t
Affiniti 70 Diagnostic Ultrasound System
EPIQ 7W Diagnostic Ultrasound System
EPIQ 7 Diagnostic Ultrasound System
Affiniti 70C Diagnostic Ultrasound System
XL14-3
X6-1
EPIQ CVxi Diagnostic Ultrasound System
EPIQ 5G Diagnostic Ultrasound System
X7-2
EPIQ 7C Diagnostic Ultrasound System
EPIQ Diagnostic Ultrasound System
C9-2
Affiniti 50 Diagnostic Ultrasound System
CX30 Diagnostic Ultrasound System
LAP L9-5
Lumify Ultrasound System
C5-2
C9-4ec
C8-4v
21373B (C5040)
EnVisor Diagnostic Ultrasound System
21350A (S8)
C6-3
21475A
21369A (Omni II)
21221B (C1914C)
21330A (S4)
21359A (L7535)
21321A (C3540)
21390A (15-61)
21223B (D5014V)
21380A (S12)
21422A
21360A (L5035)
21228B (D1914V)
S4
Lumify Diagnostic Ultrasound System
Lumify Diamond Select Diagnostic Ultrasound System
Lumify Circular Edition Diagnostic Ultrasound System
3D Auto LAA
HD9 Ultrasound System & Transducers
L9-3
D2 TC
L9-5 LAP
C9-5ec
T6H
S7-2omni
T6207
C9-4
S3-1
D2 CW
iE33 Diagnostic Ultrasound System
iU22 Diagnostic Ultrasound System
L12-5 50mm
L11-3
L8-4
L17-5
S4-1
L12-5 38mm
HD11 Diagnostic Ultrasound System
V8-4
VISIQ Diagnostic Ultrasound System
EPIQ 5 Diamond Select Ultrasound System
Affiniti CVx Ultrasound System
EPIQ CVxi Ultrasound System
Affiniti 50 Diamond Select Ultrasound System
EPIQ 7 Diamond Select Ultrasound System
EPIQ 5W Ultrasound System
EPIQ Elite Diagnostic Ultrasound System
Affiniti 30 Diamond Select Ultrasound System
EPIQ 7W Ultrasound System
Affiniti 30 Ultrasound System
Affiniti 50 Ultrasound System
EPIQ 5 Ultrasound System
EPIQ 7 Ultrasound System
Affiniti 70 Ultrasound System
EPIQ CVx Ultrasound System
Affiniti 70 Diamond Select Ultrasound System
Affiniti 50 Circular Edition Ultrasound System
EPIQ CVx Circular Edition Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
Lumify Diagnostic Ultrasound System iOS
Q-Station
EPIQ Series Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System
PercuNav
X14-3
Xperius Ultrasound System
Collaboration Live
L12-5
iU22 Ultrasound System
EPIQ Series Diagnostic Ultrasound Systems
QLAB Advanced Quantification Software
C9-4ec Transducer
HDI 5000 Diagnostic Ultrasound System
EPIQ Elite W Diagnostic Ultrasound System
L12-3 ERGO
mC7-2
V9-2
X5-1c
X3-1
Philips ultrasound probe
AAA Model
S5-2
HD15 Diagnostic Ultrasound System
S7-2omnni
Affiniti 30 Diagnostic Ultrasound System
3D8-4
C5-2 (21426A)
S8-3 (21750A)
S7-2omni (21778A)
3D6-2
PA4-2 (21422A)
T6H (21378A)
S7-3t (21781A)
S3-1 (21711A)
S12-4 (21780A)
C8-4 (21437A)
EPIQ Diagnostic Ultrasound Systems
Affiniti Diagnostic Ultrasound Systems
Cx50 Diagnostic Ultrasound System
EPIQ Circular Edition Diagnostic Ultrasound System
Affiniti Circular Edition Diagnostic Ultrasound System
PercuNav Image Fusion And Interventional Navigation
ClearVue 350 Diagnostic Ultrasound System
ClearVue 650 Diagnostic Ultrasound System
ClearVue 550 Diagnostic Ultrasound System
ClearVue 850 Diagnostic Ultrasound System
S3
ClearVue 580 Diagnostic Ultrasound System
PercuNav Coaxial Needle Tracker, 13Gx16cm
PercuNav Coaxial Needle Tracker, 13Gx11cm
PercuNav Coaxial Needle Tracker, 20Gx13cm
PercuNav Patient Tracker
PercuNav Ultrasound Tracker
PercuNav Coaxial Needle Tracker, 20Gx17cm
PercuNav Coaxial Needle Tracker, 18Gx8cm
Adaptive Needle Tracker
PercuNav Endocavity Ultrasound Tracker
PercuNav Coaxial Needle Tracker, 18Gx13cm
PercuNav Coaxial Needle Tracker, 17Gx16cm
PercuNav Coaxial Needle Tracker, 16Gx11cm
PercuNav Coaxial Needle Tracker, 20Gx8cm
PercuNav Image Fusion and Interventional Navigation
V6-2; V9-2; VL13-5
eL18-4; eL18-4 EMT
L12-3; L12-3ERGO
D2tcd; D5cwc
L12-5; L15-7io; L18-5
S4-2; S5-1
C10-4ec; D2cwc
X5-1; X6-1; X7-2; X7-2t ; X8-2t; XL14-3
S7-3t; S8-3;S8-3t; S9-2
mC7-2; mC12-3
C5-1; C6-2; C8-5; C9-2; C10-3v
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility