| 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 | 00864222000428 | RetCam Portable | The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam Portable | NATUS MEDICAL INC | |
| 2 | 00864222000411 | RetCam Shuttle | The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam Shuttle | NATUS MEDICAL INC | |
| 3 | 00864222000404 | RetCam 3 | RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy captu RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. | RetCam 3 | NATUS MEDICAL INC | |
| 4 | 00864218000104 | iScreen Vision Screener 3000 | The iScreen Vision Screener 3000 is a vision screening tool intended to capture The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals. | iScreen Vision | ISCREEN VISION, INC. | |
| 5 | 00859623006919 | DMI-1000 | 400000 | ASSEMBLY PKGD LIPISCAN - US | MEIBOMIAN GLAND EVALUATOR | TEARSCIENCE, INC. |
| 6 | 00859623006612 | LVI-2000 | 100100 | ASSEMBLY PKGD LIPIVIEW-2 - US | LIPIVIEW II OCULAR SURFACE INTERFEROMETE | TEARSCIENCE, INC. |
| 7 | 00859623006513 | LVI-1001 | 100000 | ASSEMBLY PKGD LIPIVIEW 1 - INTL | LIPIVIEW OCULAR SURFACE INTERFEROMETER | TEARSCIENCE, INC. |
| 8 | 00858848006780 | iCam100 | 700-54524-001 | iCam 12 MP | iCam | OPTOVUE, INC. |
| 9 | 00858848006766 | iFusion | 700-54542-001 | iFusion 80 with 12 MP Camera | iFusion | OPTOVUE, INC. |
| 10 | 00858848006650 | iFusion | 700-49003-005 | iVue NR for iFusion USCFG 230V | iFusion | OPTOVUE, INC. |
| 11 | 00858848006643 | iFusion | 700-49002-005 | iVue NR for iFusion 230V | iFusion | OPTOVUE, INC. |
| 12 | 00858848006636 | iFusion | 700-49001-005 | iVue NR for iFusion USCFG 120V | iFusion | OPTOVUE, INC. |
| 13 | 00858848006629 | iFusion | 700-49000-005 | iVue NR for iFusion 120V | iFusion | OPTOVUE, INC. |
| 14 | 00858848006414 | iCam100 | 700-49517-004 | iCam Camera Head 5MP | iCam | OPTOVUE, INC. |
| 15 | 00858848006339 | iCam100 | 700-49517-003 | iCam Camera Head 5 MP | iCam | OPTOVUE, INC. |
| 16 | 00858848006322 | iCam100 | 700-49517-002 | iCam Camera Head 5 MP | iCam | OPTOVUE, INC. |
| 17 | 00858848006308 | iFusion | 700-48586-003 | iVue NR for iFusion USCFG System w/ 230V Table | iFusion | OPTOVUE, INC. |
| 18 | 00858848006292 | iFusion | 700-48585-003 | iVue NR for iFusion System w/ 230V Table | iFusion | OPTOVUE, INC. |
| 19 | 00858848006278 | iCam100 | 700-49517-001 | iCam Camera Head 5 MP | iCam | OPTOVUE, INC. |
| 20 | 00858848006247 | iFusion | 700-48371-003 | iVue NR for iFusion USCFG System w/ 120V Table | iFusion | OPTOVUE, INC. |
| 21 | 00858848006230 | iFusion | 700-48363-003 | iVue NR for iFusion System w/ 120V Table | iFusion | OPTOVUE, INC. |
| 22 | 00858848006209 | iFusion | 700-49003-004 | iVue NR for iFusion USCFG 230V | iFusion | OPTOVUE, INC. |
| 23 | 00858848006193 | iFusion | 700-49002-004 | iVue NR for iFusion 230V | iFusion | OPTOVUE, INC. |
| 24 | 00858848006186 | iFusion | 700-49001-004 | iVue NR for iFusion USCFG 120V | iFusion | OPTOVUE, INC. |
| 25 | 00858848006179 | iFusion | 700-49000-004 | iVue NR for iFusion 120V | iFusion | OPTOVUE, INC. |
| 26 | 00857253006057 | PCI 40-1000 | The Phoenix ICON retinal imaging system is a wide-field, handheld, high resoluti The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. | Phoenix ICON Cart System | PHOENIX CLINICAL | |
| 27 | 00851158007690 | EFC-2600 | Non-mydriatic Auto Fundus Camera | Eli Ezer | U.S. OPHTHALMIC, L.L.C. | |
| 28 | 00850003069302 | 2.4.0 | The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 29 | 00850003069241 | 2.3.0 | The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 30 | 00850003069203 | 2.2.1 | The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 31 | 00850003069166 | 2.2.0 | The IMAGEnet 6 ver. 2.2.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 32 | 00850003069142 | 2.1.1 | The IMAGEnet 6 ver. 2.1.1 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.1.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 33 | 00850003069074 | 2.1.0 | The IMAGEnet 6 ver. 2.1.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.1.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 34 | 00850003069050 | 2.0.3 | The IMAGEnet 6 ver. 2.0.3 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.0.3 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 35 | 00850003069029 | 2.0.2 | The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 36 | 00850003069005 | 2.0 | The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the co The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 37 | 00842000100140 | 11.6.1 | Merge Eye Station | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 38 | 00811608018638 | VP2OPHK | Volk Pictor Plus VP2HAND, VP2RET and VP2ANT | VOLK OPTICAL INC. | ||
| 39 | 00811608018621 | VP2ANTK | Volk Pictor Plus VP2HAND and VP2ANT | VOLK OPTICAL INC. | ||
| 40 | 00811608018614 | VP2RETK | Volk Pictor Plus VP2HAND AND VP2RET | VOLK OPTICAL INC. | ||
| 41 | 00811608018577 | VP2ANT | Volk Pictor Plus VP2ANT | VOLK OPTICAL INC. | ||
| 42 | 00811608018560 | VP2RET | Volk Pictor Plus VP2RET | VOLK OPTICAL INC. | ||
| 43 | 00811608018003 | VP1OPHK | Volk Pictor VP1Handset, VP1RET and VP1ANT | VOLK OPTICAL INC. | ||
| 44 | 00811608017969 | VP1RETK | Volk Pictor VP1Handset, VP1RET | VOLK OPTICAL INC. | ||
| 45 | 00811608017822 | VP1ANT | Volk Pictor VP1ANT | VOLK OPTICAL INC. | ||
| 46 | 00811608017815 | VP1RET | Volk Pictor VP1RET | VOLK OPTICAL INC. | ||
| 47 | 00811608017808 | VP1HAND | Volk Pictor VP1Handset | VOLK OPTICAL INC. | ||
| 48 | 00811608012261 | VPPFUNDUSK | Pictor Prestige - Fundus Kit (VPPHAND and VPPRET) | VOLK OPTICAL INC. | ||
| 49 | 00811608012254 | VPPFULLK | Pictor Prestige - Full Kit (VPPHAND, VPPRET and VPPANT) | VOLK OPTICAL INC. | ||
| 50 | 00732094337327 | 901027 | 777-PM3WAS | GS777 IntWallSys PO MV iEx w BP ST | Welch Allyn, Inc. | WELCH ALLYN, INC. |