FDA.reportPublic FDA data

Spectral-domain optical coherence tomography system

Definition
A mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.
GUDID devices
81
Last updated
2020-02-25 23:52:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858848006735iScanOPTOVUE, INC.iVue 5002020-02-13
00858848006742iScanOPTOVUE, INC.iVue 5002020-02-13
00858848006728RTVue XR AvantiOPTOVUE, INC.1002020-02-03
04059237000464SPECTRALISHeidelberg Engineering GmbHSoftware 6.13_US2020-01-21
04059237000488SPECTRALISHeidelberg Engineering GmbHSoftware with HEYEX 2 V6.14_US2020-01-21
04057748087141CIRRUS HD-OCT Carl Zeiss Meditec, Inc.60002019-11-01
00858848006704RTVue XR AvantiOPTOVUE, INC.1002019-09-20
00858848006667RTVue XR Avanti ScannerOPTOVUE, INC.Avanti Scanner2019-06-12
00858848006674RTVue XR AvantiOPTOVUE, INC.1002019-06-12
08800019600473Optical Coherence Tomography HOCT-1Huvitz Co., Ltd.HOCT-12019-05-10
08800019600497Optical Coherence Tomography HOCT-1FHuvitz Co., Ltd.HOCT-1F2019-05-10
04059237000570SPECTRALISHeidelberg Engineering GmbHSoftware 6.12_US2019-04-23
04049471096019CIRRUS photoCarl Zeiss Meditec AGCIRRUS photo 6002015-09-17
04049471096026CIRRUS photoCarl Zeiss Meditec AGCIRRUS photo 8002015-09-17
04049539072108RESCAN 700Carl Zeiss Meditec AG72102016-09-23
04057748087080CIRRUS HD-OCTCarl Zeiss Meditec, Inc.50002016-04-15
04057748087097CIRRUS HD-OCTCarl Zeiss Meditec, Inc.5002016-08-25
04057748087127CIRRUS HD-OCTCarl Zeiss Meditec, Inc.CIRRUS Review Software2017-04-14
04059237000013SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S16002016-09-24
04059237000020SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S20002016-09-24
04059237000051SPECTRALISHeidelberg Engineering GmbHSP-PWS-2000A2016-09-24
04059237000099SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S36102016-09-24
04059237000105SPECTRALISHeidelberg Engineering GmbHProduct Family SW V6.62016-09-24
04059237000150SPECTRALISHeidelberg Engineering GmbHUWF12016-09-24
04059237000211SPECTRALISHeidelberg Engineering GmbHHMO2019-01-03
04059237000242SPECTRALIS, HRT3, HEPHeidelberg Engineering GmbHHEYEX 2 SW V2.22016-12-16
04059237000280SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S26002016-09-24
04059237000297SPECTRALISHeidelberg Engineering GmbHSPEC-CAM-S26102016-09-24
04059237000310SPECTRALISHeidelberg Engineering GmbHProduct Family SW V6.8a-US2017-06-30
04059237000501SPECTRALISHeidelberg Engineering GmbHSP-PWS-1001A2019-01-03
04059237000525SPECTRALISHeidelberg Engineering GmbHSoftware V6.10-US2019-01-03
04059237000549SPECTRALISHeidelberg Engineering GmbHSoftware with HEYEX 2 V6.10-US2019-01-03
00857691006022ENVISU C2300 VHR 120VBIOPTIGEN, INC.90-C2300-V1-1202016-09-16
00857691006053ENVISU C2300 VHR 220VBIOPTIGEN, INC.90-C2300-V1-2202016-09-16
00857691006107ENFOCUS 4400 HR 120VBIOPTIGEN, INC.90-C4450-H2-1202016-09-16
00857691006114ENFOCUS 4400 HR 220VBIOPTIGEN, INC.90-C4450-H2-2202016-09-16
00858848006001AvantiOPTOVUE, INC.RTVue XR100-12016-08-31
00858848006018iScanOPTOVUE, INC.iVue 5002016-08-31
00858848006025AvantiOPTOVUE, INC.RTVue XR100-22016-08-31
00858848006032AvantiOPTOVUE, INC.RTVue XR Scanner2016-08-31
00858848006049iVueOPTOVUE, INC.iVue 100-12016-08-31
00858848006056iVueOPTOVUE, INC.iVue 100-12016-08-31
00858848006063iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006070iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006087iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006094iVueOPTOVUE, INC.iVue 100-22016-08-31
00858848006100iVueOPTOVUE, INC.iVue 100-22016-08-31
00858848006117iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006124iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006131iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006148iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006155iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006162iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006216iVueOPTOVUE, INC.iVue 100-12016-08-31
00858848006223iVueOPTOVUE, INC.iVue 1002016-08-31
00858848006315iScanOPTOVUE, INC.iVue 5002016-08-31
00858848006346RTVue XR AvantiOPTOVUE, INC.100-32017-04-27
00858848006353RTVue XR Avanti ScannerOPTOVUE, INC.Avanti Scanner2017-04-27
00858848006360RTVue XR Avanti ScannerOPTOVUE, INC.Avanti Scanner2017-05-15
00858848006377RTVue XR Avanti ScannerOPTOVUE, INC.Avanti Scanner2017-05-15
00858848006384RTVue XR AvantiOPTOVUE, INC.100-12017-05-15
00858848006391RTVue XR AvantiOPTOVUE, INC.100-22017-05-15
00858848006407iScanOPTOVUE, INC.iVue 5002017-07-18
00858848006421iScanOPTOVUE, INC.iVue 5002017-10-31
00858848006438iScanOPTOVUE, INC.iVue 5002017-10-31
00858848006452RTVue XR AvantiOPTOVUE, INC.1002018-09-06
00858848006469RTVue XR AvantiOPTOVUE, INC.1002018-12-14
00858848006476iVueOPTOVUE, INC.iVue 1002019-01-18
00858848006483iVueOPTOVUE, INC.iVue 100-12019-01-18
00858848006490iVueOPTOVUE, INC.iVue 1002019-01-18
00858848006506iVueOPTOVUE, INC.iVue 1002019-01-18
00858848006537iVueOPTOVUE, INC.iVue 1002019-01-18
00858848006544iVueOPTOVUE, INC.iVue 1002019-01-18
00858848006551iVueOPTOVUE, INC.iVue 100-22019-01-18
00858848006568iVueOPTOVUE, INC.iVue 100-22019-01-18
00858848006605iVueOPTOVUE, INC.iVue 100-12019-01-18
00858848006612iVueOPTOVUE, INC.iVue 100-12019-01-18
00858848006629iFusionOPTOVUE, INC.iFusion2019-01-21
00858848006636iFusionOPTOVUE, INC.iFusion2019-01-21
00858848006643iFusionOPTOVUE, INC.iFusion2019-01-21