EPIQ CVx Diagnostic Ultrasound System Circular Edition

GUDID 00884838125643

VM11.0 update

Philips Ultrasound LLC

General-purpose ultrasound imaging system
Primary Device ID00884838125643
NIH Device Record Key22ad0df3-922f-4c77-b476-39ebc2caa0cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIQ CVx Diagnostic Ultrasound System Circular Edition
Version Model Number795122
Company DUNS063377717
Company NamePhilips Ultrasound LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100884838125643 [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 Date2024-06-11
Device Publish Date2024-06-03

Devices Manufactured by Philips Ultrasound LLC

00884838123625 - Ultrasound System 5500CV2025-07-28 As part of SW 2.0
00884838123632 - Ultrasound System 5500P2025-07-28 Part of SW 2.0
00884838123649 - Ultrasound System 5500W2025-07-28 Part of SW 2.0
00884838123656 - Ultrasound System 5300G2025-07-28 Part of SW 2.0
00884838123663 - Ultrasound System 5300W2025-07-28 As part of SW 2.0
00884838123670 - Ultrasound System 5300P2025-07-28 As part of SW 2.0
00884838123687 - Ultrasound System 5500G2025-07-28 As part of SW 2.0
00884838125964 - Lumify USB-C to USB-C Transducer cable2025-07-22 Lumify USB-C to USB-C Transducer cable

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