| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04987646807360 | K9L39F9K | KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. The retina image can be stored to an image filing equipment through serial interface. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA nonmyd 7 | |
| 2 | 04987646803973 | K9L51K | The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to captur The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA GENESIS-D | |
| 3 | 04987646807728 | DE2K | The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imagi The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA DR-1α | |
| 4 | 04987646806912 | SL170K/A | KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 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 affect the structural properties of the anterior eye segment. | HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | KOWA SL-17 | |
| 5 | 04987646807278 | K9L56BK | The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA VX-20 | |
| 6 | 04987646806936 | SL170K/P | KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 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 affect the structural properties of the anterior eye segment. | HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | KOWA SL-17 | |
| 7 | 04987646806905 | SL170K/W | KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 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 affect the structural properties of the anterior eye segment. | HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | KOWA SL-17 | |
| 8 | 04987646806929 | SL170K/G | KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 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 affect the structural properties of the anterior eye segment. | HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | KOWA SL-17 | |
| 9 | 04987646804109 | TO8K | The Kowa KT-800 is indicated for measuring intraocular pressure without contacti The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. | HKX | Tonometer, Ac-Powered | 2 | KOWA KT-800 | |
| 10 | 04987646807575 | K9L61K | The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic. | PJZ | Camera, Ophthalmic, General-Use | 2 | KOWA nonmyd 8 | |
| 11 | 04987646804031 | SL150K | KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magn KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand. | HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | KOWA SL-15 | |
| 12 | 04987646802006 | K9L48K | KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or wi KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA VX-10 | |
| 13 | 04987646800583 | K9L51BK | KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA GENESIS-Df | |
| 14 | 04987646807612 | K9L63K | The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic. | PJZ | Camera, Ophthalmic, General-Use | 2 | KOWA nonmyd 8s | |
| 15 | 04987646804147 | K9L48BK | KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or w KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA VX-10a | |
| 16 | 04987646804024 | LSS50BK | KOWA FM-600 is an instrument to measure the protein level contained in aqueous h KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye. | MYC | Ophthalmoscope,Laser,Scanning | 2 | KOWA FM-600 | |
| 17 | 04987646808930 | VK28UE | KOWA VK-2s is indicated for acquiring, displaying and storing image data from KO KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras. | NFJ | System, Image Management, Ophthalmic | 2 | KOWA VK-2s | |
| 18 | 04987646808923 | VK28K | KOWA VK-2s is indicated for acquiring, displaying and storing image data from KO KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras. | NFJ | System, Image Management, Ophthalmic | 2 | KOWA VK-2s | |
| 19 | 04987646808947 | VK28U2E | KOWA VK-2s is indicated for acquiring, displaying and storing image data from KO KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras. | NFJ | System, Image Management, Ophthalmic | 2 | KOWA VK-2s | |
| 20 | 04987646809128 | K9L64K | KOWA nonmyd AF is intended for use with retinal image capturing without requirin KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic. | PJZ | Camera, Ophthalmic, General-Use | 2 | KOWA nonmyd AF | |
| 21 | 04987646805113 | FT10K | KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results.Static quantitative perimetry examinations and kinetic perimetry examinations are available. | HPT | Perimeter, Automatic, Ac-Powered | 1 | KOWA AP-7000 | |
| 22 | 04987646806592 | K9L57FK | KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface. | HKI | Camera, Ophthalmic, Ac-Powered | 2 | KOWA nonmyd WX | |
| 23 | 04987646803799 | ATO-6K | For the measurement of intraocular pressure in the diagnosis of glaucoma. | HKY | Tonometer, Manual | 2 | KOWA Applanation Tonometer HA-2 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00811608018638 | VP2OPHK | Volk Pictor Plus VP2HAND, VP2RET and VP2ANT | VOLK OPTICAL INC. | ||
| 2 | 00811608018621 | VP2ANTK | Volk Pictor Plus VP2HAND and VP2ANT | VOLK OPTICAL INC. | ||
| 3 | 00811608018614 | VP2RETK | Volk Pictor Plus VP2HAND AND VP2RET | VOLK OPTICAL INC. | ||
| 4 | 00811608018577 | VP2ANT | Volk Pictor Plus VP2ANT | VOLK OPTICAL INC. | ||
| 5 | 00811608018560 | VP2RET | Volk Pictor Plus VP2RET | VOLK OPTICAL INC. | ||
| 6 | 00811608018003 | VP1OPHK | Volk Pictor VP1Handset, VP1RET and VP1ANT | VOLK OPTICAL INC. | ||
| 7 | 00811608017969 | VP1RETK | Volk Pictor VP1Handset, VP1RET | VOLK OPTICAL INC. | ||
| 8 | 00811608017822 | VP1ANT | Volk Pictor VP1ANT | VOLK OPTICAL INC. | ||
| 9 | 00811608017815 | VP1RET | Volk Pictor VP1RET | VOLK OPTICAL INC. | ||
| 10 | 00811608017808 | VP1HAND | Volk Pictor VP1Handset | VOLK OPTICAL INC. | ||
| 11 | 00811608012261 | VPPFUNDUSK | Pictor Prestige - Fundus Kit (VPPHAND and VPPRET) | VOLK OPTICAL INC. | ||
| 12 | 00811608012254 | VPPFULLK | Pictor Prestige - Full Kit (VPPHAND, VPPRET and VPPANT) | VOLK OPTICAL INC. | ||
| 13 | 00732094337327 | 901027 | 777-PM3WAS | GS777 IntWallSys PO MV iEx w BP ST | Welch Allyn, Inc. | WELCH ALLYN, INC. |
| 14 | 00627987702125 | MHRC-C1 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Mydriatic Hyperspectral Retinal Camera | OPTINA DIAGNOSTIQUES, INC | |
| 15 | 00627843652021 | RHA2020/2020-U | The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to captu The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases. | RHA | ANNIDIS HEALTH SYSTEMS CORP | |
| 16 | 00382830060110 | RETCAM-FA-UPGRADE | RetCam FA Upgrade Kit | Natus | XLTEK | |
| 17 | 00382830058681 | 60-000092 | RetCam™ Envision Portrait Lens | Natus | XLTEK | |
| 18 | 00382830058674 | 60-000090 | RetCam™ Envision 130 Degree Lens | Natus | XLTEK | |
| 19 | 00382830056335 | 61-000300 | RetCam Envision with FA | Natus | XLTEK | |
| 20 | 00382830016896 | 61-000400 | RetCam Envision without FA | Natus | XLTEK | |
| 21 | B857000 | 100 | Camera, Ophthalmic, ac-powered | CADENCE | RETINA-AI HEALTH, INC. | |
| 22 | B667PROTOZ1 | 01 | ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking di ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriaticagent) with different outline colors. | PROTOZ | NEXT SIGHT SRL | |
| 23 | B667NEXY1 | 01 | Nexy device is an automatic eye-fundus camera intended for taking digital images Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent. | NEXY | NEXT SIGHT SRL | |
| 24 | B310MP1S0 | MP-1S | The MP-1S MICRO PERIMETER is indicated for use as:·Color retinography·Fixation e The MP-1S MICRO PERIMETER is indicated for use as:·Color retinography·Fixation examiner·Fundus-related microperimetry·Visual rehabilitation | MP-1S | NIDEK TECHNOLOGIES SRL | |
| 25 | M6333974203P0 | 39-7420-3P | 39-7420-3P | HANDLE & CHARGER F/HORUS SERIES 3P | JEDMED | JEDMED INSTRUMENT COMPANY |
| 26 | M63339742030 | 39-7420-3 | 39-7420-3 | HANDLE F/FUNDUS HORUS SERIES 3 | JEDMED | JEDMED INSTRUMENT COMPANY |
| 27 | M6333974202P0 | 39-7420-2P | 39-7420-2P | HANDLE & CHARGER F/HORUS SERIES 2P | JEDMED | JEDMED INSTRUMENT COMPANY |
| 28 | M63339742020 | 39-7420-2 | 39-7420-2 | HANDLE & CHARGER F/HORUS SERIES 2 | JEDMED | JEDMED INSTRUMENT COMPANY |
| 29 | M6333974200 | 39-7420 | 39-7420 | HANDLE & CHARGER F/HORUS SCOPE | JEDMED | JEDMED INSTRUMENT COMPANY |
| 30 | M6333974080 | 39-7408 | 39-7408 | BATTERY F/HORUS +DIGITAL OTOSCOPE | JEDMED | JEDMED INSTRUMENT COMPANY |
| 31 | M6333974050 | 39-7405 | 39-7405 | HORUS + DIGITAL OTOSCOPE | JEDMED | JEDMED INSTRUMENT COMPANY |
| 32 | 08908007754075 | neo control box | 3nethra neo is a contact device to capture digital color images of the retina of 3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control. | 3nethra | FORUS HEALTH PRIVATE LIMITED | |
| 33 | 08908007754068 | neo probe | 3nethra neo is a contact device to capture digital color images of the retina of 3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control. | 3nethra | FORUS HEALTH PRIVATE LIMITED | |
| 34 | 08800023201017 | RetiCapture | RetiCapture | ILOODA.CO.,LTD | ||
| 35 | 08800019600541 | HFC-1 | HFC-1 | HFC-1 fundus camera is intended to capture digital images for the anterior and r HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health. | Fundus Camera HFC-1 | HUVITZ CO., LTD. |
| 36 | 08056098470319 | COBRA | 103303A00 V0/S10 | COBRA FUNDUS CAMERA | S4 OPTIK | COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL |
| 37 | 08053677040093 | EIDON FA | APFLAOP100 | The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent. | EIDON | CENTERVUE SPA |
| 38 | 08053677040017 | DRS | FUNDUS CAMERA | DRS | CENTERVUE SPA | |
| 39 | 06973009600011 | RetiCam 3100 | SYSEYE | CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD. | ||
| 40 | 06951214400220 | APS-DER | This system adopts the most advanced Optical-electro-mechanical Integration tech This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments. | NA | CHONGQING KANGHUARUIMING S&T CO., LTD.. | |
| 41 | 06951214400213 | APS-CER | This system adopts the most advanced Optical-electro-mechanical Integration tech This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments. | NA | CHONGQING KANGHUARUIMING S&T CO., LTD.. | |
| 42 | 06951214400084 | APS-BER | This system adopts the most advanced Optical-electro-mechanical Integration tech This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments. | NA | CHONGQING KANGHUARUIMING S&T CO., LTD.. | |
| 43 | 06951214400077 | APS-AER | This device is used to create digital colour photographic images of the ocular f This device is used to create digital colour photographic images of the ocular fundus through the pupil, to aid in diagnosing and monitoring retinal pathology. | NA | CHONGQING KANGHUARUIMING S&T CO., LTD.. | |
| 44 | 06430046260887 | 60101813A | Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Pre Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module. | Volk Pictor Prestige retinal set | OPTOMED OY | |
| 45 | 06430046260870 | 60101810A | Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior module. | Volk Pictor Prestige full set | OPTOMED OY | |
| 46 | 06430046260856 | 60101599A | Signal product set including Signal Camera. | Signal set | OPTOMED OY | |
| 47 | 06430046260832 | 41001595 | Ophthalmic fundus camera | Signal Camera | OPTOMED OY | |
| 48 | 06430046260795 | 60101078A | Optomed Aurora retinal set including Aurora camera and Aurora retinal module. | Optomed Aurora retinal set | OPTOMED OY | |
| 49 | 06430046260757 | 60100635A | Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module. | Optomed Aurora full set | OPTOMED OY | |
| 50 | 06430046260672 | 60100077A | Volk Pictor Plus retinal set | Pictor M5WEY4 Volk FN | OPTOMED OY |