EPIQ Diagnostic Ultrasound System Circular Edition

GUDID 00884838126893

EPIQ CVx Diagnostic Ultrasound System Circular Edition

Philips Ultrasound LLC

General-purpose ultrasound imaging system
Primary Device ID00884838126893
NIH Device Record Key98c749a6-ff8f-41df-87c7-16224b7e42f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIQ 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
GS100884838126893 [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 Date2025-07-01
Device Publish Date2025-06-23

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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