iMRI 1.5T A

GUDID 00857534006103

IMRIS SAE OR-DR-OR Full Body Imaging, 116116-000

DEERFIELD IMAGING, INC.

Full-body MRI system, superconducting magnet
Primary Device ID00857534006103
NIH Device Record Key990cdc65-9749-48e6-8865-958aafe290f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameiMRI 1.5T A
Version Model NumberiMRI 1.5T A, OR-DR-OR
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857534006103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

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 Date2016-09-22

On-Brand Devices [iMRI 1.5T A]

00857534006103IMRIS SAE OR-DR-OR Full Body Imaging, 116116-000
00857534006097IMRIS SAE OR-DR Partial Body Imaging, 116115-000
00857534006080IMRIS SAE OR-DR-OR Full Body Imaging, 116114-000
00857534006073IMRIS SAE OR-DR-OR Partial Body Imaging, 116113-000

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