FDA.reportPublic FDA data

ANTERION

Primary DI
04059237000617
Brand
ANTERION
Company
Heidelberg Engineering GmbH
Model
88036
Published
2022-01-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211817000AnterionHeidelberg Engineering GmbH2021-11-05OBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059237000617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059237000617040592370006174059237000617

GMDN Terms#

Term, Definition table
TermDefinition
Eye anterior segment analyserA mains electricity (AC-powered) ophthalmic instrument intended to be used to measure and evaluate various properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a computer, with installed dedicated application software; the software may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329833875
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059237000976SPECTRALISSoftware V7.4-US2026-07-07
04059237000235SPECTRALIS86549865492025-03-24
04059237000723SPECTRALISS3610 [SN>20000]2024-10-04
04059237000792SPECTRALISS2610 [SN>20000] 2024-10-04
04059237001027SPECTRALIS Software V.7.2-US 2024-10-04
04059237001034SPECTRALISSoftware V.7.2-US with Heidelberg Eye Explorer2024-10-04
04059237000884SPECTRALISS10022022-10-26
04059237000891SPECTRALISS20022022-10-26
04059237000815SPECTRALISSoftware V7.0-US2022-02-02
04059237000839SPECTRALISSoftware with HEYEX 2 V7.0-US 2022-02-02
04059237000464SPECTRALISSoftware 6.13_US2020-01-21
04059237000488SPECTRALISSoftware with HEYEX 2 V6.14_US2020-01-21
04059237000716SPECTRALISSP-PWS-2001A [>20000]2019-10-29
04059237000570SPECTRALISSoftware 6.12_US2019-04-23
04059237000594SPECTRALISSoftware with HEYEX 2 V6.12_US2019-04-23
04059237000013SPECTRALISSPEC-CAM-S16002016-09-24
04059237000020SPECTRALISSPEC-CAM-S20002016-09-24
04059237000037SPECTRALISSPEC-CAM-S36002016-09-24
04059237000044SPECTRALISSP-PWS-1000A2016-09-24
04059237000051SPECTRALISSP-PWS-2000A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885022330005EnFocus 2300 Integrated OCT SystemLEICA INSTRUMENTS (SINGAPORE) PTE LIMITEDOBO2026-07-30
04059237000976SPECTRALISHeidelberg Engineering GmbHOBO2026-07-07
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
04059237000723SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
00857691006039ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2024-05-02
04059237000938ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04059237000945ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.OBO2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.OBO2023-06-12
04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04059237000884SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000877ANTERIONHeidelberg Engineering GmbHOBO2022-09-29
04059237000754ANTERIONHeidelberg Engineering GmbHOBO2022-02-14
04059237000815SPECTRALISHeidelberg Engineering GmbHOBO2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHOBO2022-02-02
045711302829573D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2022-01-28
03615020000496ANAEYES OCT for system linkageESSILOR INTERNATIONALOBO2021-02-18
04571130282186ANTERIOR ATTACHMENT HA-2TOPCON CORPORATIONOBO2021-02-03
04571130282193ANTERIOR SEGMENT ATTACHMENT KIT AA-1TOPCON CORPORATIONOBO2021-01-15
00850003069302IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-12-09
00857691006374ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2020-11-19
00858848006766iFusionOPTOVUE, INC.OBO2020-08-24
00850003069241IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-06-23