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510(k) Data Aggregation
K Number
K011877Device Name
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
Manufacturer
CARL ZEISS JENA GMBH
Date Cleared
2001-09-26
(103 days)
Product Code
HKI, NFF, NFG
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
CARL ZEISS JENA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FF450 plus VISUPAC system is intended to capture, display, store, and manipulate images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
Device Description
The FF450 plus VISUPAC system and the predicate devices use monocular ophthalmic cameras that function according to the same principles of operation and technological characteristics. Light from an external light source is used to generate images of the eye which are captured using the fundus camera, displayed on a monitor, stored on electronic media by a computer system, and manipulated by the user via the system software.
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