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Ophtalmology assessments and diagnosis instruments
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Ophtalmology assessments and diagnosis instruments - medical device software
Ophtalmology assessments and diagnosis instruments - medical device software
Z12120192
28 devices
Devices
Z12120192
Ural Telekomüni̇kasyon San. Ti̇c. A.ş
·
,
TR
Class I
CE/MDR
Ophthalmic Software Platform RX (RX Capture for Retinal Camera +2 more)
Canon Inc.
·
,
JP
Class IIa
CE/MDR
GUDID
on market
Ophthalmic Slit Lamp Microscope
Chongqing Fanji Medical Equipment Co., Ltd.
·
,
CN
Class I
CE/MDR
RS Plus
IDCP Solutions BV
·
,
NL
Class I
CE/MDR
Eyecheck System Image Viewer
Eys AS
·
,
NO
Class IIa
CE/MDR
easee online vision checker
easee b.v.
·
,
NL
Class IIa
CE/MDR
RetinAI Macula Biomarkers
Ikerian AG
·
,
CH
Class IIa
CE/MDR
easee online eye exam
easee b.v.
·
,
NL
Class IIa
CE/MDR
easee online visual acuity test
easee b.v.
·
,
NL
Class IIa
CE/MDR
Umi Dr
ULMA Medical Technologies, S.L.U.
·
,
ES
Class IIa
CE/MDR
OPHTHALMIC DATA SYSTEM IMAGEnet 7
Topcon Corporation
·
,
JP
Class IIa
CE/MDR
VUNO Med-Fundus AI
VUNO Inc.
·
,
KR
Class IIa
CE/MDR
ITOS standalone
Voigtmann GmbH
·
,
DE
Class IIa
CE/MDD
EyeArt
Eyenuk, Inc.
·
,
US
Class IIa
FDA 510(k)
K200667
Active
Cleared 3 Aug 2020
CE/MDD
+1
authorizations
Assure Plus
Eyetelligence Pty Ltd, an Optain Health Company
·
,
AU
Class IIa
CE/MDR
OPHTHALMIC DATA SYSTEM IMAGEnet 6
Open recall
Topcon Corporation
·
,
JP
Class IIa
FDA 510(k)
K171370
Active
Cleared 1 Nov 2017
FDA 510(k)
K232828
Active
Cleared 1 Mar 2024
+1
authorizations
Kay Pictures Ltd iSight Pro
Kay Pictures
·
,
GB
Class I
CE/MDR
Image Filing Software NAVIS-EX
Nidek Co., Ltd.
·
,
JP
Class IIa
CE/MDR
4202074CE05
Expiring
Valid to Nov 2026
FDA 510(k)
K181345
Active
Cleared 19 Jul 2018
Mona Dr
MONA.health
·
,
BE
Class I
CE/MDD
RetinAI OCT Atlas
Ikerian AG
·
,
CH
Class IIa
CE/MDR
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