iMRX System

GUDID 00857534006141

iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000

DEERFIELD IMAGING, INC.

Full-body MRI system, superconducting magnet
Primary Device ID00857534006141
NIH Device Record Key949228a7-8f88-4f77-b614-eaf74ffb7546
Commercial Distribution StatusIn Commercial Distribution
Brand NameiMRX System
Version Model NumberANTERIOR ASSY, 3T 16CH CARDIAC COIL
Company DUNS079990922
Company NameDEERFIELD IMAGING, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857534006141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZISystem, X-Ray, Angiographic

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 Date2016-11-04

On-Brand Devices [iMRX System]

00857534006189iMRX System AR-DR MR30RS,105824-000
00857534006172iMRX System AR-DR-AR, MR30R, 105826-000
00857534006165iMRX System AR-DR-OR, MR30R, 105828-000
00857534006158iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000
00857534006141iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000
00857534006127iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000
00857534006110iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000

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