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

Table, Radiologic (KXJ) (5) Coil, Magnetic Resonance, Specialty (MOS) (4) Table, Operating-Room, Ac-Powered (FQO) (3) Table, Operating-Room, Electrical (GDC) (2) System, Digital Image Communications, Radiological (LMD) (1)

Premarket Exempt

No Yes

Clear

HC150 - 1.5T Head Coil Lower - 00857534006448 Catalog Number :

Device Description : LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-600

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

ORT300 Table - 00857534006462 Catalog Number :

Device Description : ORT300 Modular Table Main Unit Assy, 114093-600

Device Class : 1

Duns Number: 079990922

Premarket Exempt : Yes

Product Code : KXJ, FQO

Prescription Use : Yes

Device Count : 1

ORT200 Table - 00857534006479 Catalog Number :

Device Description : ORT200 50/60Hz Covered Table Assy V2, 114148-600

Device Class : 1

Duns Number: 079990922

Premarket Exempt : Yes

Product Code : KXJ, FQO

Prescription Use : Yes

Device Count : 1

ORT100 Table - 00857534006486 Catalog Number :

Device Description : T2X OR Table V.2, 110470-600

Device Class : 1

Duns Number: 079990922

Premarket Exempt : Yes

Product Code : FQO, KXJ

Prescription Use : Yes

Device Count : 1

VISIUSmatrix - 00857534006493 Catalog Number :

Device Description : Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000

Device Class : 1

Duns Number: 079990922

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

ORT 400 (Trumpf TruSystem 7500 MR) table - 00857534006509 Catalog Number :

Device Description : ORT 400 (Trumpf TruSystem 7500 MR) table, Control Panel Assy 119409-000

Device Class : 1

Duns Number: 079990922

Premarket Exempt : Yes

Product Code : GDC, KXJ

Prescription Use : No

Device Count : 1

ORT 400 (Trumpf TruSystem 7500 MR) table - 00857534006516 Catalog Number :

Device Description : ORT 400 (Trumpf TruSystem 7500 MR) table Assembly, 119493-000

Device Class : 1

Duns Number: 079990922

Premarket Exempt : Yes

Product Code : KXJ, GDC

Prescription Use : No

Device Count : 1

HC150 - 1.5T Head Coil Lower Neuro II-S - 00857534006523 Catalog Number :

Device Description : LOWER COIL ASSEMBLY, 1.5T Neuro II-S, 119980-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

HC150 - 1.5T Head Coil Upper Assy Neuro II S - 00857534006530 Catalog Number :

Device Description : Upper Coil Assemblt 1.5T Neuro II-S, 119976-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

InSitu Coil - 00857534006547 Catalog Number : 120018-000

Device Description : InSitu Coil, Open, 1.5T Large 120018-000

Device Class : 2

Duns Number: 079990922

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

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