Philips Radiology Smart Assistant

GUDID 00884838104013

Philips Medical Systems DMC GmbH

Diagnostic x-ray digital imaging system workstation application software
Primary Device ID00884838104013
NIH Device Record Key30585b7b-bebd-498d-af92-afe79fd98ffc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips Radiology Smart Assistant
Version Model Number30000581513X
Company DUNS314101218
Company NamePhilips Medical Systems DMC GmbH
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
GS100884838104013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-26
Device Publish Date2022-01-18

Devices Manufactured by Philips Medical Systems DMC GmbH

00884838125322 - Grid Landscape for SkyPlate E 2025-06-27
00884838125339 - Grid Landscape for SkyPlate large 2025-06-27
00884838125346 - Grid Portrait for SkyPlate E 2025-06-27
00884838125353 - Grid Portrait for SkyPlate large2025-06-27
00884838125360 - Grid Portrait for SkyPlate small 2025-06-27
00884838125384 - Grid Portrait Fiber PaxScan4336W2025-06-27
00884838125391 - Grid Landscape Fiber PaxScan4336W2025-06-27
00884838125421 - X-Ray Grid 40/12/1402025-06-27

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