CLARUS

Primary DI
04057748096051
Brand
CLARUS
Company
Carl Zeiss Meditec, Inc.
Model
CLARUS Review Software
Device description
The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS Review Software can be installed on a separate review station (PC or laptop) for data review and analysis.
Published
2017-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QERCamera, Ophthalmic, Slit-Scanning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QERCamera, Ophthalmic, Slit-ScanningOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181444000CLARUSCarl Zeiss Meditec, Inc.2019-01-10QER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057748096051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057748096051040577480960514057748096051

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.

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
04057748087097CIRRUS HD-OCT5002016-08-25
04057748087127CIRRUS HD-OCTCIRRUS Review Software2017-04-14
04057748096044CLARUS7002019-07-01
04057748085284Humphrey Field Analyzer 3 (HFA3) HFA3 Review Software2019-03-22
04057748096037CLARUS5002017-09-25
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
04057748096044CLARUSCarl Zeiss Meditec, Inc.QER2019-07-01
04057748096037CLARUSCarl Zeiss Meditec, Inc.QER2017-09-25