FDA.reportPublic FDA data

Ox-Imager

Primary DI
00859806007016
Brand
Ox-Imager
Company
MODULATED IMAGING INC.
Model
CS
Device description
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.
Published
2018-01-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153426000Ox-Imager CSModulated Imaging, Inc.2016-12-21MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859806007016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859806007016008598060070168598060070160859806007016

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeterA mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603130928
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859806007030Clarifi Cart0859806007032019-04-03
00859806007023Clarifi Imaging SystemClarifi2018-12-21

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Primary DI, Brand, Company table
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10884521824416INVOSCovidien LPMUD2023-11-03