dS TorsoCardiac 1.5T

GUDID 00884838096813

The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

Philips Healthcare (Suzhou) Co., Ltd.

MRI system coil, radio-frequency
Primary Device ID00884838096813
NIH Device Record Keya6f85889-3cfe-4066-8e86-a9b071b897c3
Commercial Distribution StatusIn Commercial Distribution
Brand NamedS TorsoCardiac 1.5T
Version Model Number45980168199X
Company DUNS421265537
Company NamePhilips Healthcare (Suzhou) Co., Ltd.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838096813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-25
Device Publish Date2022-04-17

Devices Manufactured by Philips Healthcare (Suzhou) Co., Ltd.

00884838096813 - dS TorsoCardiac 1.5T2022-04-25The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
00884838096813 - dS TorsoCardiac 1.5T2022-04-25 The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that ca
00884838096820 - dS MSK S 1.5T2022-04-25 The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that ca
00884838096837 - dS MSK M 1.5T2022-04-25 The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that ca
00884838105508 - Incisive CT2022-01-07 The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconst
00884838095199 - DigitalDiagnost C502020-09-14 Stationary x-ray system
00884838095205 - DuraDiagnost2020-09-14 Stationary x-ray system
00884838085015 - Incisive CT2019-10-09
00884838082366 - DigitalDiagnost C502018-07-06 The DigitalDiagnost C50 is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or te

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.