FDA.reportPublic FDA data

Scanning-laser ophthalmic imaging system

Definition
An assembly of mains electricity (AC-powered) ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.
GUDID devices
23
Last updated
2019-11-08 21:39:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04059237000716SPECTRALISHeidelberg Engineering GmbHSP-PWS-2001A [>20000]2019-10-29
04059237000594SPECTRALISHeidelberg Engineering GmbHSoftware with HEYEX 2 V6.12_US2019-04-23
04059237000037SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S36002016-09-24
04059237000044SPECTRALISHeidelberg Engineering GmbHSP-PWS-1000A2016-09-24
04059237000068SPECTRALISHeidelberg Engineering GmbHSP-PWS-2001A2016-09-24
04059237000075SPECTRALISHeidelberg Engineering GmbHSPEC-TSP2016-09-24
04059237000082SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S16102016-09-24
04059237000112SPECTRALISHeidelberg Engineering GmbHVAO2016-09-24
04059237000136SPECTRALISHeidelberg Engineering GmbHWFO22016-09-24
04059237000259SPECTRALISHeidelberg Engineering GmbHImage Capture Module SW V1.22016-09-24
04059237000303SPECTRALISHeidelberg Engineering GmbHProduct Family SW V6.8-US2017-06-12
04059237000341SPECTRALISHeidelberg Engineering GmbHProduct Family SW V6.9.1-US2018-07-11
04059237000358SPECTRALISHeidelberg Engineering GmbHProduct Famliy with HEYEX 2 SW V6.9b-US2018-07-11
04589662680028Laser Speckle Flowgraphy LSFG-NAVISOFTCARE CO., LTD.LSFG-NAVI-NM22018-02-19
04712826770680LightMed TruScan 577LIGHTMED CORPORATIONML00152016-09-23
05057056003856Optos OCT/SLOOPTOS PUBLIC LIMITED COMPANYOCT2016-11-23
05057056010212Panoramic OphthalmoscopeOPTOS PUBLIC LIMITED COMPANYP2002016-05-27
05057056100210Panoramic OphthalmoscopeOPTOS PUBLIC LIMITED COMPANYP200C2016-05-27
05057056100920Panoramic OpthalmoscopeOPTOS PUBLIC LIMITED COMPANY200Tx2016-11-23
05057056106007Panoramic OphthalmoscopeOPTOS PUBLIC LIMITED COMPANYP200T2016-05-27
05057056106397OPTOS ADVANCE IMAGE SERVEROPTOS PUBLIC LIMITED COMPANYA106392016-05-27
05057056106502Panoramic OphthalmoscopeOPTOS PUBLIC LIMITED COMPANYP200DTx2016-05-27
05057056106885OPTOS ADVANCE IMAGE SERVEROPTOS PUBLIC LIMITED COMPANYA106882016-05-27