Duns Number:314594680
Device Description: The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Catalog Number
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Brand Name
CIRRUS photo
Version/Model Number
CIRRUS photo 800
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
f3192e6b-f466-484a-93a0-e9857415d3d6
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
September 17, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| 3 | A medical device with high risk that requires premarket approval | 1 |