DEERFIELD IMAGING, INC.

Address:5101 Shady Oak Rd,Minnetonka,MN,55343,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Nuclear Magnetic Resonance Imaging (LNH) (9) System, X-Ray, Angiographic (IZI) (7) Coil, Magnetic Resonance, Specialty (MOS) (1)

Premarket Exempt

No Yes

Clear

iMRI 1.5T A - 00857534006103 Catalog Number :

Device Description : IMRIS SAE OR-DR-OR Full Body Imaging, 116116-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006110 Catalog Number :

Device Description : iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : IZI, LNH

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006127 Catalog Number :

Device Description : iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : IZI, LNH

Prescription Use : Yes

Device Count : 1

HC150 - 1.5T Head Coil Lower - 00857534006134 Catalog Number :

Device Description : LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006141 Catalog Number :

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

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : IZI, LNH

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006158 Catalog Number :

Device Description : iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : IZI, LNH

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006165 Catalog Number :

Device Description : iMRX System AR-DR-OR, MR30R, 105828-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : LNH, IZI

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006172 Catalog Number :

Device Description : iMRX System AR-DR-AR, MR30R, 105826-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : IZI, LNH

Prescription Use : Yes

Device Count : 1

iMRX System - 00857534006189 Catalog Number :

Device Description : iMRX System AR-DR MR30RS,105824-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : IZI, LNH

Prescription Use : Yes

Device Count : 1

Neuro III-SV iMRI System - 00857534006196 Catalog Number :

Device Description : Neuro III-SV Multi-Room Imaging Suite MR30RS Enhancement [OR-DR-OR], 118396-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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