FDA.reportPublic FDA data

CIRRUS HD-OCT

Primary DI
04057748087097
Brand
CIRRUS HD-OCT
Company
Carl Zeiss Meditec, Inc.
Model
500
Device description
The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures.
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K150977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150977000CIRRUS HD-OCTCarl Zeiss Meditec, Inc.2015-09-01OBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057748087097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057748087097040577480870974057748087097

GMDN Terms#

Term, Definition table
TermDefinition
Spectral-domain optical coherence tomography systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
362747011
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057748087141CIRRUS HD-OCT 60002019-11-01
04057748087080CIRRUS HD-OCT50002016-04-15
04057748087127CIRRUS HD-OCTCIRRUS Review Software2017-04-14
04057748096044CLARUS7002019-07-01
04057748085284Humphrey Field Analyzer 3 (HFA3) HFA3 Review Software2019-03-22
04057748096037CLARUS5002017-09-25
04057748096051CLARUSCLARUS Review Software 2017-09-25
04057748087110PLEX Elite90002017-04-14
04057748081118ATLAS Corneal Topography System90002018-06-13
04057748085215Humphrey FDT7102018-06-13
04057748085239Humphrey Matrix 8002018-06-13
04057748085246Humphrey Field Analyzer 3 (HFA3)8302017-01-11
04057748085253Humphrey Field Analyzer 3 (HFA3)8402017-01-11
04057748085260Humphrey Field Analyzer 3 (HFA3)8502017-01-11
04057748085277Humphrey Field Analyzer (HFA3)8602017-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04059237000617ANTERIONHeidelberg Engineering GmbHOBO2022-01-03
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
00857691006367ENVISU C2300 VHR 100VBIOPTIGEN, INC.OBO2020-06-01