SACCADOMETER

Primary DI
05906874392010
Brand
SACCADOMETER
Company
OBER CONSULTING SP Z O O
Model
PLUS
Device description
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software.The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage.Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLLMonitor, Eye Movement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLLMonitor, Eye MovementOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152890000SACCADOMETER PLUS, SACCADOMETER ADVANCEDOber Consulting Sp. Z.O.O.2016-08-11HLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05906874392010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05906874392010059068743920105906874392010

GMDN Terms#

Term, Definition table
TermDefinition
Eye movement analysis systemAn assembly of mains electricity (AC-powered) devices designed to measure, evaluate and record the movement of the eyes. The device is intended to measure ocular dynamics, typically measuring both horizontal and vertical eye movements. This device can include a stimulus source (e.g., a light bar), a sensing device (e.g., video or infrared cameras), a computer, and a recorder. Some systems may include cameras and/or eyelid trackers mounted on spectacles or headbands.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+48505940787info@ober-consulting.com

Regulatory Flags#

DUNS number
522393420
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05906874392027SACCADOMETERADVANCED2017-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011292104RetitrackC. Light Technologies, Inc.HLL2024-10-18
00860011292111RetitrackC. Light Technologies, Inc.HLL2024-10-18
05906874392027SACCADOMETEROBER CONSULTING SP Z O OHLL2017-01-26
00851158007379Eli EzerU.S. OPHTHALMIC, L.L.C.HLL2016-09-28
00851158007386Eli Ezer U.S. OPHTHALMIC, L.L.C.HLL2016-09-28