EPIQ 5W Diagnostic Ultrasound System

GUDID 00884838114128

Software version-10.0.X

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID00884838114128
NIH Device Record Key52ff5777-82cf-4b59-894b-d608d05af271
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIQ 5W Diagnostic Ultrasound System
Version Model Number795204
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838114128 [Primary]

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-18
Device Publish Date2023-05-10

Devices Manufactured by Philips Ultrasound, Inc.

00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition2024-04-18 10.0.X Circular Edition
00884838114210 - EPIQ 5 Diagnostic Ultrasound System Circular Edition2024-04-18 10.0.X Circular Edition
00884838114227 - EPIQ CVx Diagnostic Ultrasound System Circular Edition2024-04-18 10.0.X Circular Edition
00884838114234 - EPIQ Elite Diagnostic Ultrasound System Circular Edition2024-04-18 10.0.X Circular Edition
00884838102729 - Transducer X11-4t2024-04-11
00884838115323 - QLAB Advanced Quantification Software2024-04-11
00884838122116 - Lumify Diagnostic Ultrasound System2024-04-08 Android 5.0
00884838120266 - Lumify Diagnostic Ultrasound System iOS2023-08-08 Release 5.0 iOS

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