FDA Registration
Active
🇺🇸 United States
Philips Ultrasound LLC
Reg #: 3019216
·
FEI: 3019216
·
Expires 2026
Products
9
Proprietary Names
267
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Philips Ultrasound LLC
- Registration Number
- 3019216
- FEI Number
- 3019216
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 22100 Bothell Everett Hwy
- City
- BOTHELL
- State
- WA
- ZIP
- 98021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240980
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 | 2024-11-05 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-11-05 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-11-05 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2024-11-05 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-11-05 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-09-22 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2013-11-18 |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | Class 2 | Radiology | No | 2026-06-09 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2006-02-21 |
Proprietary Names
EPIQ Elite Diamond Select Ultrasound System;
EPIQ CVx Diamond Select Ultrasound System;
EPIQ CVx Diagnostic Ultrasound System;
EPIQ 7W Diagnostic Ultrasound System;
EPIQ 5 Circular Edition Ultrasound System;
EPIQ Elite Circular Edition Ultrasound System;
EPIQ 5 Diagnostic Ultrasound System;
EPIQ 7 Diagnostic Ultrasound System;
EPIQ Diagnostic Ultrasound System;
EPIQ 7C Diagnostic Ultrasound System;
EPIQ 7G Diagnostic Ultrasound System;
EPIQ 5C Diagnostic Ultrasound System;
EPIQ 7 Diamond Select Ultrasound System;
EPIQ CVxi Diagnostic Ultrasound System;
EPIQ 5G Diagnostic Ultrasound System;
EPIQ 5 Diamond Select Ultrasound System;
EPIQ 5W Diagnostic Ultrasound System;
EPIQ 7 Circular Edition Ultrasound System;
EPIQ Elite W Diagnostic Ultrasound System;
EPIQ Elite Diagnostic Ultrasound System;
EPIQ CVx Circular Edition Ultrasound System;
Collaboration Live
L12-5
iU22 Ultrasound System
PercuNav
EPIQ 5G Diagnostic Ultrasound System
D2tcd
S8-3t
C6-2
X7-2t
EPIQ Elite W Diagnostic Ultrasound System
Affiniti 70W Diagnostic Ultrasound System
S12-4
S9-2
S5-1
C5-1
VL13-5
L12-3 ERGO
EPIQ Diagnostic Ultrasound System
EPIQ 7G Diagnostic Ultrasound System
EPIQ 7C Diagnostic Ultrasound System
EPIQ 7W Diagnostic Ultrasound System
BP10-5ec
L12-4
Affiniti 70C Diagnostic Ultrasound System
3D9-3v
D2cwc
X8-2t
XL14-3
L18-5
C8-5
Affiniti 70 Diagnostic Ultrasound System
Affiniti 50W Diagnostic Ultrasound System
EPIQ CVxi Diagnostic Ultrasound System
S7-3t
D5cwc
EPIQ 5 Diagnostic Ultrasound System
X7-2
Affiniti 50G Diagnostic Ultrasound System
V6-2
eL18-4
L12-5 50
mC7-2
Affiniti 50C Diagnostic Ultrasound System
Affiniti 50 Diagnostic Ultrasound System
X8-2ti
EPIQ 7 Diagnostic Ultrasound System
C9-2
C9-4v
S4-2
L15-7io
X5-1
C10-4ec
V9-2
L12-3
S8-3
EPIQ CVx Diagnostic Ultrasound System
EPIQ 5C Diagnostic Ultrasound System
EPIQ 5W Diagnostic Ultrasound System
X6-1
EPIQ Elite Diagnostic Ultrasound System
Affiniti 70G Diagnostic Ultrasound System
C10-3v
X5-1c
Lumify Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System
EPIQ Series Diagnostic Ultrasound System
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
EPIQ 5 Diamond Select 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 7 Diamond Select Ultrasound System
EPIQ CVx Circular Edition Ultrasound System
EPIQ 7W Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
Affiniti 50 Circular Edition Ultrasound System
QLAB Advanced Quantification Software
X3-1
iE33 Diagnostic Ultrasound System
iU22 Diagnostic Ultrasound System
Philips ultrasound probe
8V3A Sector Transducer
12L5A Linear Array Transducer
8EC4A Curved Array Transducer
9MC3 Curved Array Transducer
5C2A Curved Linear Array Transducer
4V2A Sector Transducer
HDI 5000 Diagnostic Ultrasound System
L12-5 38mm
L12-5 50mm
Lumify Diamond Select Diagnostic Ultrasound System
Lumify Circular Edition 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
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
X14-3
TOMTEC-ARENA
TomTec-Arena
HD11 Diagnostic Ultrasound System
C6-3
V8-4
L9-3
EPIQ Series Diagnostic Ultrasound Systems
HD9 Ultrasound System & Transducers
Lumify Ultrasound System
C5-2
Epiq Series Diagnostic Ultrasound System
Lumify 5.2 (Lung APP-3)
C8-4v
3D6-2
S4-1
ClearVue 550 Diagnostic Ultrasound System
ClearVue 650 Diagnostic Ultrasound System
ClearVue 350 Diagnostic Ultrasound System
ClearVue 580 Diagnostic Ultrasound System
Transducer mL26-8
InnoSight Diagnostic Ultrasound System Transducers: S4-2, C9-4v, L12-4, C6-2
CX50 Diagnostic Ultrasound System
Q-Station
Xperius Ultrasound System
Sparq Diagnostic Ultrasound System
C9-3v
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
EPIQ Elite Diamond Select Ultrasound System
Affiniti CVx Circular Edition Ultrasound System
EPIQ CVx Diamond Select Ultrasound System
PercuNav Image Fusion and Interventional Navigation System
Ultrasound Workspace
C9-4ec Transducer
VISIQ Diagnostic Ultrasound System
Affiniti 30 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
S5-2
HD15 Diagnostic Ultrasound System
S7-2omnni
IntelliSpace PACS Anywhere
FetView OBGYN Cloud Reporting
Ultrasound System 5500G Ultrasound System
12L5A Linear Array Transduce
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
Flash Ultrasound System 5100 Point of Care
S3
LVivo View Selection
LVivo Seamless
Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5
Image-Arena and Image-Arena Applications
EPIQ Diagnostic Ultrasound Systems
Affiniti Diagnostic Ultrasound Systems
Cx50 Diagnostic Ultrasound System
EPIQ Circular Edition Diagnostic Ultrasound System
Affiniti Circular Edition Diagnostic Ultrasound System
Transducer X11-4t
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
L11-3
L17-5
CX30 Diagnostic Ultrasound System
LAP L9-5
PercuNav Image Fusion And Interventional Navigation
AAA Model
ClearVue 850 Diagnostic Ultrasound System
3D Auto LAA
Lumify Diagnostic Ultrasound System iOS
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility