FDA Registration
Active
🇺🇸 United States
Philips Ultrasound LLC
Reg #: 3017894900
·
FEI: 3017894900
·
Expires 2026
Products
8
Proprietary Names
228
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Philips Ultrasound LLC
- Registration Number
- 3017894900
- FEI Number
- 3017894900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223771
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 Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-02-20 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-02-20 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-02-20 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-02-20 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2024-04-26 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-05-22 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2020-05-22 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2006-02-21 |
Proprietary Names
Lumify Diagnostic Ultrasound System
Ultrasound System 5500W
5000 Compact Series Ultrasound Systems
Ultrasound System 5500P
Premium Compact Cart
Ultrasound System 5500G
Ultrasound System 5500CV
Ultrasound System 5300P
Extended Compact Cart
Ultrasound System 5300W
Deluxe Compact Cart
Ultrasound System 5300G
EPIQ 5 Diagnostic Ultrasound System
EPIQ Elite Diamond Select Ultrasound System
Affiniti 50C Diagnostic Ultrasound System
EPIQ 5 Diamond Select Ultrasound System
Affiniti 50W Diagnostic Ultrasound System
EPIQ 7 Diagnostic Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
Affiniti 50 Diamond Select Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
EPIQ Elite W Diagnostic Ultrasound System
Affiniti CVx Ultrasound System
Affiniti 70 Diagnostic Ultrasound System
EPIQ 7 Diamond Select Ultrasound System
EPIQ 7W Diagnostic Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
EPIQ 7G Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System
Affiniti 50 Diagnostic Ultrasound System
EPIQ Diagnostic Ultrasound System
EPIQ 5G Diagnostic Ultrasound System
EPIQ CVx Circular Edition Ultrasound System
EPIQ 5C Diagnostic Ultrasound System
EPIQ CVx Diagnostic Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
Affiniti 70G Diagnostic Ultrasound System
Affiniti 30 Diamond Select Ultrasound System
Affiniti 50G Diagnostic Ultrasound System
Affiniti CVx Circular Edition Ultrasound System
Affiniti 50 Circular Edition Ultrasound System
EPIQ CVx Diamond Select Ultrasound System
EPIQ CVxi Diagnostic Ultrasound System
EPIQ Elite Diagnostic Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
EPIQ 5W Diagnostic Ultrasound System
Affiniti 70 Diamond Select Ultrasound System
EPIQ 7C Diagnostic Ultrasound System
Affiniti 70C Diagnostic Ultrasound System
Affiniti 70W Diagnostic Ultrasound System
EPIQ CVxi Ultrasound System
EPIQ 7 Ultrasound System
Affiniti 30 Ultrasound System
EPIQ 5W Ultrasound System
Affiniti 50 Ultrasound System
EPIQ Series Diagnostic Ultrasound System
Affiniti 70 Ultrasound System
EPIQ CVx Ultrasound System
EPIQ 5 Ultrasound System
EPIQ 7W Ultrasound System
Transducer mL26-8
PercuNav Image Fusion And Interventional Navigation
Xperius Ultrasound System
L12-4
S4-1
Lumify Diagnostic Ultrasound System iOS
C5-2
S4-2
S8-3
C9-2
BP10-5ec
X7-2
C6-2
S5-1
S12-4
C9-4v
L18-5
X5-1
L12-5 50
D2tcd
X6-1
X7-2t
3D9-3v
S7-3t
D5cwc
C10-3v
C8-5
VL13-5
V6-2
C10-4ec
Affiniti 30 Diagnostic Ultrasound System
L12-3
D2cwc
C5-1
L15-7io
C9-3v
CX50 Diagnostic Ultrasound System
3D8-4
C5-2 (21426A)
HD11 Diagnostic Ultrasound System
S8-3 (21750A)
S7-2omni (21778A)
C9-5ec
L8-4
L12-5
3D6-2
PA4-2 (21422A)
C9-4
T6H (21378A)
S7-3t (21781A)
S3-1 (21711A)
S12-4 (21780A)
C8-4 (21437A)
Collaboration Live
S5-2
HD15 Diagnostic Ultrasound System
S7-2omnni
L9-3
C8-4v
C6-3
IntelliSpace PACS Anywhere
FetView OBGYN Cloud Reporting
HDI 5000 Diagnostic Ultrasound System
L12-5 38mm
L12-5 50mm
Q-Station
PercuNav Image Fusion and Interventional Navigation System
S8-3t
S9-2
X8-2ti
eL18-4
X8-2t
XL14-3
Sparq Diagnostic Ultrasound System
ClearVue 350 Diagnostic Ultrasound System
ClearVue 650 Diagnostic Ultrasound System
ClearVue 550 Diagnostic Ultrasound System
ClearVue 850 Diagnostic Ultrasound System
HD9 Ultrasound System & Transducers
Lumify Diamond Select Diagnostic Ultrasound System
Lumify Circular Edition Diagnostic Ultrasound System
CX30 Diagnostic Ultrasound System
C9-3io
LAP L9-5
QLAB Advanced Quantification Software
AAA Model
EPIQ Series Diagnostic Ultrasound Systems
Lumify 5.2 (Lung APP-3)
PercuNav
Lumify Ultrasound System
ClearVue 580 Diagnostic Ultrasound System
L10-4lap
CX50 Diamond Select Diagnostic Ultrasound System
Sparq Diamond Select Diagnostic Ultrasound System
CX50 Circular Edition Diagnostic Ultrasound System
Sparq Circular Edition Diagnostic Ultrasound System
C9-4ec
21373B (C5040)
EnVisor Diagnostic Ultrasound System
21350A (S8)
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
Transducer X11-4t
C9-4ec Transducer
iU22 Ultrasound System
V8-4
S3
VISIQ Diagnostic Ultrasound System
L12-3 ERGO
mC7-2
V9-2
X5-1c
iU22 Diagnostic Ultrasound System
D2 TC
L9-5 LAP
T6H
S7-2omni
T6207
S3-1
D2 CW
iE33 Diagnostic Ultrasound System
L11-3
L17-5
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
X14-3
EPIQ Diagnostic Ultrasound Systems
Affiniti Diagnostic Ultrasound Systems
Cx50 Diagnostic Ultrasound System
EPIQ Circular Edition Diagnostic Ultrasound System
Affiniti Circular Edition Diagnostic Ultrasound System
X3-1
Philips ultrasound probe
3D Auto LAA
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
Manufacture Medical Device