FDA.reportPublic FDA data

VISUPAC 500

Primary DI
04049471094077
Brand
VISUPAC 500
Company
Carl Zeiss Meditec AG
Model
VISUPAC 500
Device description
The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented.
Published
2016-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFFDevice, Storage, Images, Ophthalmic
NFGDevice, Communications, Images, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFFDevice, Storage, Images, OphthalmicRadiology1
NFGDevice, Communications, Images, OphthalmicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049471094077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049471094077040494710940774049471094077

GMDN Terms#

Term, Definition table
TermDefinition
Posterior eye segment analyser softwareAn application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the posterior eye segment performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height400Millimeter
Weight14Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314594680
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14

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Primary DI, Brand, Company table
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04549292182729CANON INC.CANON INC.NFF2020-10-16
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00380659982682VERION™Alcon Laboratories, Inc.NFG2020-08-31
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00380659982811VERION™Alcon Laboratories, Inc.NFF2020-08-31
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04049471100020FORUM Viewer AppCarl Zeiss Meditec AGNFG2018-03-22
04987669100523Image filing softwareNIDEK CO.,LTD.NFF2016-08-26
04987669100523Image filing softwareNIDEK CO.,LTD.NFG2016-08-26
04987669100554NON-MYDRIATIC AUTO FUNDUS CAMERANIDEK CO.,LTD.NFF2016-06-24
04987669100554NON-MYDRIATIC AUTO FUNDUS CAMERANIDEK CO.,LTD.NFG2016-06-24
03596010589637INTEGRATION BROKERSmith & Nephew, Inc.NFG2016-04-12
03596010588371N/ASmith & Nephew, Inc.NFG2016-04-12
03596010588388INTEGRATION BROKERSmith & Nephew, Inc.NFG2015-08-29