Affiniti CVx Ultrasound System

GUDID 00884838106598

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
Primary Device ID00884838106598
NIH Device Record Key9a9cbbd7-03a0-44b3-9c83-eb38e4eadf8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti CVx Ultrasound System
Version Model Number795190
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
GS100884838106598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-29
Device Publish Date2021-09-21

Devices Manufactured by Philips Ultrasound, Inc.

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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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