Spectral CT System Upgrades 728335

GUDID 00884838119253

Philips Medical Systems Nederland B.V.

Full-body CT system
Primary Device ID00884838119253
NIH Device Record Key12d6ff8d-b3d1-4ae6-9b0e-52a4fc97df3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectral CT System Upgrades
Version Model NumberSpectral CT System Upgrades
Catalog Number728335
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 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
GS100884838119253 [Primary]

FDA Product Code

JAKSystem, x-ray, tomography, computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-25

Devices Manufactured by Philips Medical Systems Nederland B.V.

00884838119253 - Spectral CT System Upgrades2025-06-02
00884838119253 - Spectral CT System Upgrades2025-06-02
00884838126381 - eCareManager2025-03-25 Telehealth Center Product License
00884838127746 - Radiology Operations Command Center Console2025-03-24
00884838121263 - Philips IntelliSite Pathology Solution2025-03-04 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
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

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