CIRRUS HD-OCT - The CIRRUS™ HD-OCT is a non-contact, high - Carl Zeiss Meditec, Inc.

Duns Number:362747011

Device Description: The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagin The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiformlayer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT Angiography is indicated as an aid in the visualization of vascular structures ofthe retina and choroid. The CIRRUS HD-OCT is indicated as a diagnostic device to aid in thedetection and management of ocular diseases including, but not limited to, macular holes,cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

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More Product Details

Catalog Number

-

Brand Name

CIRRUS HD-OCT

Version/Model Number

CIRRUS Review Software

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OBO

Product Code Name

Tomography, Optical Coherence

Device Record Status

Public Device Record Key

d97a352c-f4e4-4d49-9d98-5e36eb135dbd

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

April 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARL ZEISS MEDITEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 8