Interventional Workspot 001000

GUDID 00884838059191

Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software
Primary Device ID00884838059191
NIH Device Record Key84c067b4-5fd0-4465-a548-5897eb67196b
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterventional Workspot
Version Model NumberInterventional Workspot R1
Catalog Number001000
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 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
GS100884838059191 [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 StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-10-24
Device Publish Date2016-09-24

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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