Lumify Diamond Select System

GUDID 00884838104617

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
Primary Device ID00884838104617
NIH Device Record Key587b4243-85d4-4772-a9ac-452c1a6fdbe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumify Diamond Select System
Version Model Number795123
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
GS100884838104617 [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 Date2021-06-01
Device Publish Date2021-05-24

Devices Manufactured by Philips Ultrasound, Inc.

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
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

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