mC7-2

GUDID 00884838088160

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838088160
NIH Device Record Key8f652ffa-f376-47a6-b86c-dfbbeeb55ae1
Commercial Distribution StatusIn Commercial Distribution
Brand NamemC7-2
Version Model Number989605486021
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
GS100884838088160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-29
Device Publish Date2018-11-17

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.