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510(k) Data Aggregation
K Number
K182491Device Name
Applanation tonometer AT-2
Manufacturer
Takagi Seiko Co., Ltd.
Date Cleared
2018-12-10
(90 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
Takagi Seiko Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Applanation Tonometer AT-2 is intended to measure intraocular pressure for use as an aid in glaucoma screening and diagnosis.
Device Description
The device consists of a pressurizing force control unit, tonometer tip (hereinafter referred to as measuring prism), section connected to a slit lamp microscope, and accessories. The measuring prism requires disinfection. The device includes no electrical elements. The device is set up to a dedicated support on the slit lamp, and used together with a commercially available slit lamp microscope. The pressurizing force control unit of the device incorporates a measurement dial that indicates pressurizing force, including a pressurizing force control knob, and a prism holder to mount the measuring prism. Also, the pressurizing force control unit includes a connector for a calibrator to check the pressurizing force of the device. The product is a manual medical device.
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K Number
K172728Device Name
Applanation tonometer AT-1
Manufacturer
TAKAGI SEIKO CO., LTD.
Date Cleared
2017-10-17
(36 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
TAKAGI SEIKO CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Applanation Tonometer AT-1 is indicated to measure intraocular pressure for use as an aid in glaucoma screening and diagnosis.
Device Description
The device consists of a pressurizing force control unit, tonometer tip (hereinafter referred to as measuring prism), section connected to a slit lamp microscope, and accessories. The measuring prism requires disinfection. The device is available in two models according to the difference in the method of connecting to a slit lamp microscope, while the pressurizing force control unit and measuring prism are the same for the two models. Each model includes no electrical elements. The device is set up to a dedicated support on the slit lamp, and used together with a commercially available slit lamp microscope. The pressurizing force control unit of the device incorporates a measurement dial that indicates pressurizing force, including a pressurizing force control knob, and a prism holder to mount the measuring prism. Also, the pressurizing force control unit includes a connector for mounting a check weight holder to check the pressurizing force of the device. The product is a manual medical device.
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K Number
K152535Device Name
Z5 Slit lamp microscope, Z2 Slit lamp microscope
Manufacturer
TAKAGI SEIKO CO., LTD.
Date Cleared
2016-05-26
(265 days)
Product Code
HJO, DEV
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
TAKAGI SEIKO CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.
Device Description
An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
An AC-Powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.
The patient sits in front of the slit lamp with his chin in the chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. Various maqnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally and vertically, and the angle between the illumination unit and the microscope can also be varied horizontally.
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K Number
K063352Device Name
ELLEX SLIT LAMP, MODEL 30XL
Manufacturer
TAKAGI SEIKO CO., LTD.
Date Cleared
2007-03-13
(127 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
TAKAGI SEIKO CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.
Device Description
Not Found
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