Ultrasound Workspace

GUDID 00884838125186

Philips Ultrasound LLC

Radiological PACS software
Primary Device ID00884838125186
NIH Device Record Key7162f9b1-3f32-461a-931a-508881b2dc3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound Workspace
Version Model Number6.0.2.0
Company DUNS063377717
Company NamePhilips Ultrasound LLC
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 Datetrue
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
GS100884838125186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-01
Device Publish Date2025-03-24

Devices Manufactured by Philips Ultrasound LLC

00884838126893 - EPIQ Diagnostic Ultrasound System Circular Edition2025-07-01 EPIQ CVx Diagnostic Ultrasound System Circular Edition
00884838126909 - Affiniti CVx Diagnostic Ultrasound System 2025-07-01 Affiniti CVx Diagnostic Ultrasound System
00884838126923 - EPIQ Diagnostic Ultrasound System2025-07-01 EPIQ CVx Diagnostic Ultrasound System
00884838126930 - EPIQ Diagnostic Ultrasound System2025-07-01 EPIQ CVxi Diagnostic Ultrasound System
00884838126947 - Affiniti CVx Diagnostic Ultrasound System Circular Edition2025-07-01 Affiniti CVx Diagnostic Ultrasound System Circular Edition
00884838115354 - Ultrasound System 5100 POC2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
00884838120174 - Ultrasound System 5100 POC Pro2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
00884838125186 - Ultrasound Workspace2025-04-01
00884838125186 - Ultrasound Workspace2025-04-01
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