Spectral CT on Rails

GUDID 00884838103627

Philips Medical Systems Nederland B.V.

Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system
Primary Device ID00884838103627
NIH Device Record Key8d4c5f9f-b95f-4083-828f-a21aec12aed0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectral CT on Rails
Version Model Number728334
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 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
GS100884838103627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-07-21
Device Publish Date2022-07-13

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00884838123809 - IntelliSpace Radiology 2024-04-12 IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicia
00884838111110 - LumiGuide2024-04-01 Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the p
00884838111127 - LumiGuide2024-04-01 Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the p
10884838111148 - LumiGuide2024-04-01 The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide W
00884838117785 - Dunlee2024-02-08 1.5T 8CH T/R Knee Coil

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