FDA Registration Active 🇺🇸 United States

PercuNav Coaxial Needle Tracker, 18Gx8cm

Reg #: 3017894900 · FEI: 3017894900 · Expires 2025
Products
3
Proprietary Names
14
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Philips Ultrasound LLC
Registration Number
3017894900
FEI Number
3017894900
Status
Active
Expiry Year
2025
Initial Importer
No
Address
222 Jacobs Street
City
Cambridge
State
MA
ZIP
02141
Country
US

Regulatory Submissions

510(k) Number
K170716

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
System, Image Processing, Radiological LLZ
System, Imaging, Pulsed Echo, Ultrasonic IYO
System, X-Ray, Tomography, Computed JAK

Proprietary Names

PercuNav Coaxial Needle Tracker, 18Gx8cm PercuNav Coaxial Needle Tracker, 20Gx13cm PercuNav Coaxial Needle Tracker, 20Gx17cm PercuNav Ultrasound Tracker PercuNav Endocavity Ultrasound Tracker PercuNav Image Fusion and Interventional Navigation PercuNav Coaxial Needle Tracker, 17Gx16cm PercuNav Patient Tracker Adaptive Needle Tracker PercuNav Coaxial Needle Tracker, 13Gx16cm PercuNav Coaxial Needle Tracker, 16Gx11cm PercuNav Coaxial Needle Tracker, 18Gx13cm PercuNav Coaxial Needle Tracker, 20Gx8cm PercuNav Coaxial Needle Tracker, 13Gx11cm

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility