Ingenuity TF

GUDID 00884838059443

Philips Medical Systems (cleveland), Inc.

PET/CT system
Primary Device ID00884838059443
NIH Device Record Key66cb8c43-4e19-410e-a7df-f89d31fc8680
Commercial Distribution StatusIn Commercial Distribution
Brand NameIngenuity TF
Version Model Number882442
Company DUNS001224989
Company NamePhilips Medical Systems (cleveland), Inc.
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
GS100884838059443 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Philips Medical Systems (cleveland), Inc.

00884838102965 - Pinnacle Radiation Therapy Planning System 2021-08-06
00884838103566 - Pinnacle Radiation Therapy Planning System 2021-08-06
00884838074200 - Philips2020-03-06 Pinnacle Radiation Therapy Planning System Version 16.0.0.60013
00884838085602 - Philips2020-03-06 Pinnacle Radiation Therapy Planning System Version 16.0.1.60003
00884838091122 - Philips2020-03-06 Pinnacle3 Radiation therapy treatment planning system version 16.2.1.60098
00884838098992 - Philips2020-03-06 Pinnacle Radiation Therapy Planning System Version 16.4.0.60093
00884838059528 - Ingenuity Flex2019-07-15
00884838059443 - Ingenuity TF2018-07-06
00884838059443 - Ingenuity TF2018-07-06

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