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

00884838125186 - Ultrasound Workspace2025-04-01
00884838125186 - Ultrasound Workspace2025-04-01
00884838108592 - Transducer mL26-82025-02-24
00884838124912 - EPIQ Elite Diagnostic Ultrasound System2024-12-27 EPIQ Elite Diagnostic Ultrasound System VM 12.0.
00884838124974 - Affiniti 30 Ultrasound System2024-12-27 Affiniti 30 Ultrasound System VM 12.0
00884838124981 - Affiniti 50 Ultrasound System2024-12-27 VM12.0
00884838124998 - Affiniti 70 Ultrasound System2024-12-27 VM12.0
00884838109995 - EPIQ 7C Diagnostic Ultrasound System Circular Edition2024-08-19 VM 11.0 update
00884838100213 - Transducer C5-1 2024-08-07 Introduction of C5-1 (Shanghai Version) to rest of the world.

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