iU22 Diagnostic Ultrasound System

GUDID 00884838025172

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
Primary Device ID00884838025172
NIH Device Record Key45de25ac-0030-4eda-90be-932291a55a86
Commercial Distribution StatusIn Commercial Distribution
Brand NameiU22 Diagnostic Ultrasound System
Version Model Number8500-0064-02
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838025172 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-12
Device Publish Date2016-08-25

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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