DEVICE: SPECULAR MICROSCOPE (04987669100530)
Device Identifier (DI) Information
SPECULAR MICROSCOPE
CEM-530
In Commercial Distribution
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution
NIDEK CO.,LTD.
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45721 | Optical pachymeter |
A mains electricity (AC-powered), ophthalmic, device that uses optics to measure the thickness of the cornea. Using optical low coherence reflectometry (OLCR) this device can possibly measure corneal thicknesses to a precision of one micron without having to make contact with the eye surface and no contact fluids are required, nor will it induce any indentation. This device, also known as a pachometer, will provide data that is used to evaluate the results of eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], monitor epithelium regrowth, and for other ophthalmic measurement evaluations.
|
Obsolete | false |
46787 | Direct ophthalmoscope, line-powered |
A mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NQE | Microscope, Specular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a25178a7-e538-460d-85bf-7a9ac62f5b91
March 29, 2018
2
August 26, 2016
March 29, 2018
2
August 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-223-9044
info@nidek.com
info@nidek.com