FDA.reportPublic FDA data

ATLAS Corneal Topography System

Primary DI
04057748081118
Brand
ATLAS Corneal Topography System
Company
Carl Zeiss Meditec, Inc.
Model
9000
Device description
The ZEISS ATLAS Corneal Topography System is intended to measure and analyze thecorneal curvature of the eye.
Published
2018-06-13
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJBInstrument, Measuring, Corneal Radius

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJBInstrument, Measuring, Corneal RadiusOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057748081118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057748081118040577480811184057748081118

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography systemAn assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
362747011
Device count
1
Premarket exempt
true
No natural rubber latex
true

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
04057748096051CLARUSCLARUS Review Software 2017-09-25
04057748087110PLEX Elite90002017-04-14
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

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Primary DI, Brand, Company table
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