Enterprise Viewer 839064

GUDID 00884838107595

The Enterprise Viewer is used for image distribution within the enterprise. It is used by clinicians as the primary user interface to view and interact with images. It is also used by Radiologists as a lightweight form to access images where they don’t have access to the complete diagnostic workstations. Enterprise Viewer is accessed through an HTML5 browser either over a desktop or using a capable mobile device.

Philips Medical Systems Nederland B.V.

Radiological PACS software
Primary Device ID00884838107595
NIH Device Record Key7a0dce66-2c7b-4074-8b52-0a3f2a5cf4a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnterprise Viewer
Version Model Number15.X
Catalog Number839064
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
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
GS100884838107595 [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 Date2024-11-25
Device Publish Date2024-11-15

Devices Manufactured by Philips Medical Systems Nederland B.V.

00884838127609 - DUNLEE SENTINELLE2025-01-20 ADD-ON ACCESSORIES BREAST SEN MR SET contains - 2 Fiducial Marker Grid Block Assembly and 1 BREAST GRID (USER STERILIZED)
00884838119277 - Philips Sentinelle2024-12-25 dS 1.5T Interface Box
00884838119284 - Philips Sentinelle2024-12-25 dS 3.0T Interface Box
00884838119291 - Philips Sentinelle2024-12-25 dS 1.5T 8CH Medial
00884838119307 - Philips Sentinelle2024-12-25 dS 3.0T 8CH Medial
00884838119314 - Philips Sentinelle2024-12-25 dS 1.5T 4CH Lateral Left
00884838119321 - Philips Sentinelle2024-12-25 dS 3.0T 4CH Lateral Left
00884838119338 - Philips Sentinelle2024-12-25 dS 1.5T 4CH Lateral Right

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