FDA Registration
Active
🇺🇸 United States
Philips Ultrasound LLC
Reg #: 2518586
·
FEI: 2518586
·
Expires 2026
Products
6
Proprietary Names
186
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Philips Ultrasound LLC
- Registration Number
- 2518586
- FEI Number
- 2518586
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 Echo Dr
- City
- Reedsville
- State
- PA
- ZIP
- 17084
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242670
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 | 2025-06-09 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-06-09 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-06-09 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-07-29 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-07-29 |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | Class 2 | Radiology | No | 2026-06-09 |
Proprietary Names
Lumify Diagnostic Ultrasound System
C8-4v
3D6-2
S5-1
X7-2t
S4-2
C9-4v
CX50 Diagnostic Ultrasound System
Sparq Diagnostic Ultrasound System
L12-4
C6-2
C5-1
C9-3v
D5cwc
L12-3
Affiniti Series Diagnostic Ultrasound System
EPIQ Series Diagnostic Ultrasound System
Epiq Series Diagnostic Ultrasound System
iU22 Diagnostic Ultrasound System
Xperius Ultrasound System
C5-2
S4-1
Lumify Ultrasound System
HD11 Diagnostic Ultrasound System
BP10-5ec
V6-2
C6-3
V8-4
L9-3
ClearVue 550 Diagnostic Ultrasound System
ClearVue 650 Diagnostic Ultrasound System
ClearVue 350 Diagnostic Ultrasound System
3D9-3v
ClearVue 580 Diagnostic Ultrasound System
D2cwc
S5-2
HD15 Diagnostic Ultrasound System
S12-4
S7-2omnni
L15-7io
L12-5
S8-3
C8-5
X3-1
iE33 Diagnostic Ultrasound System
Philips ultrasound probe
Affiniti 70G Diagnostic Ultrasound System
C10-3v
L18-5
C10-4ec
S8-3t
Affiniti 50C Diagnostic Ultrasound System
EPIQ 5C Diagnostic Ultrasound System
L12-5 50
Affiniti 70W Diagnostic Ultrasound System
EPIQ 7G Diagnostic Ultrasound System
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
S7-3t
Affiniti 50W Diagnostic Ultrasound System
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
C9-4ec Transducer
ClearVue 850 Diagnostic Ultrasound System
VISIQ Diagnostic Ultrasound System
3D8-4
C5-2 (21426A)
S8-3 (21750A)
S7-2omni (21778A)
C9-5ec
L8-4
PA4-2 (21422A)
C9-4
T6H (21378A)
S7-3t (21781A)
S3-1 (21711A)
S12-4 (21780A)
C8-4 (21437A)
D2 TC
L9-5 LAP
T6H
S7-2omni
T6207
S3-1
D2 CW
L12-5 50mm
L11-3
L17-5
L12-5 38mm
Ultrasound System 5500CV
Ultrasound System 5300P
Ultrasound System 5500P
Ultrasound System 5300W
Ultrasound System 5500G Ultrasound System
Ultrasound System 5300G
Ultrasound System 5500W
Lumify Diamond Select Diagnostic Ultrasound System
Lumify Circular Edition Diagnostic Ultrasound System
EPIQ Series Diagnostic Ultrasound Systems
EPIQ Elite W Diagnostic Ultrasound System
L12-3 ERGO
mC7-2
V9-2
EPIQ Elite Diagnostic Ultrasound System
X5-1c
L10-4lap
C9-3io
CX50 Diamond Select Diagnostic Ultrasound System
Sparq Diamond Select Diagnostic Ultrasound System
CX50 Circular Edition Diagnostic Ultrasound System
Sparq Circular Edition Diagnostic Ultrasound System
X14-3
EPIQ CVx Diamond Select Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
Transducer X11-4t
EPIQ CVx Circular Edition Ultrasound System
EPIQ 7 Diamond Select Ultrasound System
EPIQ Elite Diamond Select Ultrasound System
EPIQ 5 Diamond Select Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
iU22 Ultrasound System
EPIQ Diagnostic Ultrasound Systems
QLAB Advanced Quantification Software
Affiniti Diagnostic Ultrasound Systems
Cx50 Diagnostic Ultrasound System
EPIQ Circular Edition Diagnostic Ultrasound System
Affiniti Circular Edition Diagnostic Ultrasound System
Affiniti 30 Diagnostic Ultrasound System
Lumify 5.2 (Lung APP-3)
Lumify Diagnostic Ultrasound System iOS
EPIQ CVxi Ultrasound System
EPIQ 7 Ultrasound System
Affiniti 30 Ultrasound System
Affiniti 70 Diamond Select Ultrasound System
EPIQ 5W Ultrasound System
Affiniti 50 Ultrasound System
Affiniti 70 Ultrasound System
EPIQ CVx Ultrasound System
Affiniti 50 Diamond Select Ultrasound System
EPIQ 5 Ultrasound System
Affiniti CVx Ultrasound System
Affiniti 30 Diamond Select Ultrasound System
EPIQ 7W Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
Affiniti 50 Circular Edition Ultrasound System
CX30 Diagnostic Ultrasound System
LAP L9-5
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
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility