CX50 SYSTEM UPTRADE

GUDID 00884838103214

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
Primary Device ID00884838103214
NIH Device Record Key48435234-151c-4d1f-bc29-281f27b19b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameCX50 SYSTEM UPTRADE
Version Model Number795045
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 Batchtrue
Serial Numberfalse
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
GS100884838103214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-10-29
Device Publish Date2020-10-21

Devices Manufactured by Philips Ultrasound, Inc.

00884838120266 - Lumify Diagnostic Ultrasound System iOS2023-08-08 Release 5.0 iOS
00884838121423 - TOMTEC ARENA2023-07-27
00088483810859 - Transducer mL26-82023-05-30
00884838114128 - EPIQ 5W Diagnostic Ultrasound System2023-05-18 Software version-10.0.X
00884838114111 - EPIQ 5 Diagnostic Ultrasound System2023-05-17 Software version-10.0.X
00884838114098 - EPIQ 7 Diagnostic Ultrasound System2023-05-12 Software version - 10.0.x
00884838114104 - EPIQ 7W Diagnostic Ultrasound System2023-05-12 Software version - 10.0.x
00884838114135 - EPIQ CVx Diagnostic Ultrasound System2023-05-12 Software version 10.0.X

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