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Found 3 results
510(k) Data Aggregation
K Number
K221601Device Name
MS-39
Manufacturer
C.S.O. S.r.l.
Date Cleared
2023-09-01
(456 days)
Product Code
OBO, MXK
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
C.S.O. S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MS-39 is designed to capture scans of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - anterior and posterior corneal shape (elevation maps, curvature maps, power maps); - anterior chamber features (Anterior Chamber Depth ACD, Aqueous Depth AD); - corneal thickness (Central Corneal Thickness CCT, corneal thickness map); - corneal epithelia map; - corneal stroma map; - lens thickness.
Device Description
Not Found
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K Number
K132987Device Name
COBRA FUNDUS CAMERA
Manufacturer
C.S.O. S.R.L.
Date Cleared
2014-07-03
(282 days)
Product Code
HKI, NFJ
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
C.S.O. S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CSO Cobra Fundus Camera is intended for taking digital images of a human retina with or without the use of mydriatic agent. The retinal image can be stored to an image filing device.
Device Description
Cobra is intended for taking digital images of a human retina with or without the use of a mydriatic agent. A function for retinal plane capturing is provided. The instrument is furnished with an integrated 5MP CCD camera, and uses one (1) white LED for flashing, one (1) IR led for alignment and Infrared acquisitioning.
Cobra can be used with pupil diameters starting from 2.5 mm, and therefore can be used without the need for a mydriatic agent. Acquisition transfer is performed from the instrument to the accompanying PC via a Firewire cable.
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K Number
K022054Device Name
F 900
Manufacturer
C.S.O. S.R.L.
Date Cleared
2002-08-06
(43 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
C.S.O. S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea)
Device Description
Not Found
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