FDA.reportPublic FDA data

EasyScan

Primary DI
08719326032108
Brand
EasyScan
Company
EasyScan B.V.
Model
EasyScan
Device description
Scanning Laser Ophthalmoscope
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYCOphthalmoscope,Laser,Scanning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYCOphthalmoscope, Laser, ScanningOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111988000EASYSCAN MODEL 1.2I-Optics BV2011-10-28MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326032108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326032108087193260321088719326032108

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Contacts#

Phone, Email table
PhoneEmail
+31703993112support@i-optics.com

Regulatory Flags#

DUNS number
491666469
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
G744OCUB100OcuMet BeaconOcuSciences, Inc.MYC2025-06-25
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
04059237000723SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.MYC2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.MYC2023-06-12
04059237000884SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000815SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
00849233012066Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
10849233012063Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
04059237000464SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
04059237000488SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
08053677040116DRSplusCENTERVUE SPAMYC2019-12-09
04059237000716SPECTRALISHeidelberg Engineering GmbHMYC2019-10-29
05057056107509OCT Ophthalmoscope OPTOS PUBLIC LIMITED COMPANYMYC2019-10-29
04059237000570SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000594SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000211SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000501SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000525SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000549SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
08053677040093EIDONCENTERVUE SPAMYC2018-07-23
04059237000341SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11
04059237000358SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11