FDA.reportPublic FDA data

Infrascanner

Primary DI
00861606000302
Brand
Infrascanner
Company
INFRASCAN, INC.
Model
2000
Catalog number
2000
Device description
Handheld Brain Hematoma Detector
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OPTInfrared Hematoma Detector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPTInfrared Hematoma DetectorOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120949000INFRASCANNERInfrascan, Inc.2013-01-11OPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861606000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861606000302008616060003028616060003020861606000302

GMDN Terms#

Term, Definition table
TermDefinition
Intracranial haematoma detectorA noninvasive, hand-held, rechargeable battery-powered device intended to be used to scan a patient¿s head for the detection of an intracranial (e.g., epidural, subdural and intracerebral) haematoma, using near infrared (NIR) technology. It consists of a control unit which emits an infrared laser, measures reflection with an optical detector, and displays processed results. Typically, the recorded patient data from the scan can be downloaded from the device for further assessment by a medical professional.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153408179
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861606000326Infrascanner250025002023-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10076490716568KIMTECHAnsell Healthcare ProductOPT2025-07-21
00861606000326InfrascannerINFRASCAN, INC.OPT2023-06-14