Promaxo, Inc.

Address:70 Washington Street,Oakland,CA,94607,US

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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

Coil, Magnetic Resonance, Specialty (MOS) (8) System, Nuclear Magnetic Resonance Imaging (LNH) (2)

Premarket Exempt

Clear

MRI Large Receive Coil - 00850042098028 Catalog Number : 6761-L

Device Description : The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

MRI Medium Receive Coil - 00850042098035 Catalog Number : 6761-M

Device Description : The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Fiducial Coil with Arm Mount (Receive Only) - 00850042098042 Catalog Number : 7181

Device Description : The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

MRI Large RX Coil (Receive Only) - 00850042098080 Catalog Number : 6761-L

Device Description : The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil with external feedbox and fiducial coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

MRI Medium RX Coil (Receive Only) - 00850042098097 Catalog Number : 6761-M

Device Description : The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil with external feedbox and fiducial coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Template Arm - 00850042098103 Catalog Number : 17279

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Promaxo MRI System - 00860006901110 Catalog Number : PR071-001-M

Device Description : Magnetic Resonance Imaging System, Magnet Cart

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : LNH, MOS

Prescription Use : Yes

Device Count : 1

Promaxo MRI System - 00860006901127 Catalog Number : PR071-001-R

Device Description : Magnetic Resonance Imaging System, Auxiliary Rack

Device Class : 2

Duns Number: 103665187

Premarket Exempt : No

Product Code : LNH, MOS

Prescription Use : Yes

Device Count : 1

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