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510(k) Data Aggregation
K Number
K201325Device Name
Optomed Smartscope M5 with Optomed Smartscope FA
Manufacturer
Optomed Oyj
Date Cleared
2020-11-20
(186 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Optomed Oyj
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.
Device Description
Optomed Smartscope M5 camera with Smartscope FA optics module is designed for use in a medical environment. Captured images and video are used for documentation and consultation. Optomed Smartscope M5 camera has a memory card where captured images and recorded videos are saved. Optomed Smartscope M5 camera is used with interchangeable optics modules previously cleared Smartscope EY4 and Smartscope ES2 and subject device Smartscope FA. Optics modules are attached to the camera with bayonet connectors.
Optomed Smartscope FA optics module is designed for fundus fluorescein angiography imaging of the human eye. Optomed Smartscope FA optics module includes two light sources: Blue light and infrared light, optical component that reflects light to the optical path and lenses that guide light through the pupil to the back of the eye and back to the camera sensor. Optomed Smartscope FA optics module has nine internal fixation targets for the patient to fixate on during imaging. Optomed Smartscope FA optics module receives power from Optomed Smartscope M5 digital camera.
Optomed Smartscope M5 camera has a WLAN module inside and when WLAN is used, Optomed Smartscope M5 camera transfers captured images and recorded videos to the PC automatically immediately after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Charging Station and the USB cable is connected between Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.
Optomed Smartscope M5 camera has a rechargeable Ni-MH battery that is charged when the camera is placed on Charging Station, which is connected to the mains by power supply cable. Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Smartscope M5 camera is not used, it may be stored on Charging Station. Storing the device on Optomed Smartscope M5 camera Charging Station is not harmful for the battery.
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K Number
K180378Device Name
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Manufacturer
Optomed Oy
Date Cleared
2018-04-05
(52 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Optomed Oy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye.
Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye.
Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.
Device Description
Optomed Aurora device set for ophthalmic imaging consists of Optomed Aurora Camera, Optomed Aurora Retinal Module and Optomed Aurora Anterior Module with following accessories Optomed Aurora Charging Station, USB cable, power supply, eye cups (2 pcs), batteries (2 pcs), USB flash drive and cleaning cloth.
Optomed Aurora Camera is designed for use in a medical environment. Captured images and video are used for documentation. Optomed Aurora Camera has a memory card where captured images and recorded videos are saved. Optomed Aurora Camera is used with interchangeable optics modules Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. Optics modules are attached to the camera with bayonet connectors.
Optomed Aurora Retinal Module is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Optomed Aurora Retinal Module has nine internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The material of the eye cup is Momentive LIM 6030AB.
Optomed Aurora Anterior Module has two light sources for imaging eye surface and surrounding areas: white and cobalt blue light enables capturing of fluorescent images. There are four focus windows to focus the image. The material of the eye cup is Momentive Silopren LSR 4040.
Optomed Aurora Camera has a WLAN module inside and when WLAN is used, Optomed Aurora Camera transfers captured images and recorded videos to the PC automatically after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Optomed Aurora Charging Station and the USB cable is connected between Optomed Aurora Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.
Optomed Aurora Camera has a rechargeable Li-ion battery that is charged when the camera is placed on Optomed Aurora Charging Station, which is connected to the mains by power supply cable. Optomed Aurora Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Aurora Camera is not used, it may be stored on Optomed Aurora Charging Station. Storing the device on Optomed Aurora Charging Station is not harmful for the battery.
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K Number
K163021Device Name
HAAG-STREIT FUNDUS MODULE 300
Manufacturer
OPTOMED OY
Date Cleared
2017-04-11
(162 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
OPTOMED OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.
Device Description
FUNDUS MODULE 300 device set for retinal imaging consists of FUNDUS MODULE 300 Camera with base plate, lens cover, battery and camera USB cable (0.6 m), and FUNDUS MODULE 300 Cradle with power supply and cradle USB cable (1.5 m). FUNDUS MODULE 300 is used with dedicated HAAG-STREIT slit lamps. FUNDUS MODULE 300 is designed to be used in medical environment and it is intended for nonmydriatic imaging of the fundus of the human eve for documentation and consultation. In nonmydriatic imaging no mydriatic is needed because infrared light is used for the targeting image to the fundus and visible light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. Constant white light illumination for targeting can be selected from device menu if mydriatic drops are used. Images can also be taken using infrared lightning for both aiming and capturing. The FUNDUS MODULE 300 has 9 internal fixation targets for the patient to fixate at during imaging. The middle fixation target provides a macula centred image. FUNDUS MODULE 300 can be used together with HAAG-STREIT Release Module RM02 and HAAG-STREIT EyeSuite software. Controlling the FUNDUS MODULE 300 can be performed by Camera keys or by Release Module RM02. Captured images and recorded videos are automatically transferred to the PC (EyeSuite software) after imaging. Images and videos are stored on the micro SDHC memory card and can be also transferred to the PC by using Cradle USB connection. FUNDUS MODULE 300 Camera has rechargeable Li-lon battery and the device is charged by using the Cradle. Materials of outer shells of the FUNDUS MODULE 300 are plastic, aluminum and silicon. There is no applied parts (no parts which are designed to come into physical contact with the patient) in FUNDUS MODULE 300.
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K Number
K132186Device Name
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
Manufacturer
OPTOMED OY
Date Cleared
2013-12-18
(156 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
OPTOMED OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.
Device Description
Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. The device set for retinal imaging consists of: Camera handset M5, Attachable ophthalmic lens EY4, Eye cup for EY4, Cradle for charging and image transfer, Slit Lamp Adapter. Optomed Smartscope M5 with optics module ES2 is intended to capture images and the surface of the human eye and surrounding areas. The device set for anterior ophthalmic imaging consists of: Camera handset M5, Attachable anterior ophthalmic lens ES2, Cradle for charging and image transfer. EY4 has an LED light source with visible white and infrared light. Also red light target LED's are used to eye position fixation during imaging. ES2 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.
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K Number
K110986Device Name
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
Manufacturer
OPTOMED OY
Date Cleared
2011-05-16
(38 days)
Product Code
HKI, HLI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
OPTOMED OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.
Device Description
Optomed Smartscope M5 is a hand-held digital ophthalmoscope that together with the optics modules EY3 and ES1 is used to capture digital images and video of fundus and surrounding area of the human eye. M5 EY3 has an LED light source with visible white light and infrared light. M5 ES1 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.
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K Number
K092056Device Name
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
Manufacturer
OPTOMED OY
Date Cleared
2009-10-01
(86 days)
Product Code
HKI, HLI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
OPTOMED OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.
Device Description
Optomed Smartscope M3-1 EY1 is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye. M3-1 EY1 has a LED light source. Image data is stored on the Flash memory card using 6.6 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.
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