MODULATED IMAGING INC.

Address:2400 Barranca Pkwy.,Irvine,CA,92606,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

Oximeter, Tissue Saturation (MUD) (3)

Premarket Exempt

Clear

Ox-Imager - 00859806007016 Catalog Number :

Device Description : The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasi The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygensaturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations.

Device Class : 2

Duns Number: 603130928

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Clarifi Imaging System - 00859806007023 Catalog Number :

Device Description : Tissue Saturation Oximeter

Device Class : 2

Duns Number: 603130928

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Clarifi Cart - 00859806007030 Catalog Number :

Device Description : Cart

Device Class : 2

Duns Number: 603130928

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

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