DEVICE: ECHOSCAN (04987669100448)

Device Identifier (DI) Information

ECHOSCAN
US-4000
In Commercial Distribution

NIDEK CO.,LTD.
04987669100448
GS1

1
690635461 *Terms of Use
Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is 20,000 Hz or more. In the medical field, ultrasonic waves of frequencies between 1 and 15 MHz are applied, and these types of high sound waves have the following characteristics similar to light: They have a high tendency to travel in a straight direction. They have characteristics such as reflect.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ultrasound pachymeter A mains electricity (AC-powered), ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. A small ultrasound probe(s) that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. The data is used to evaluate refractive eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], evaluate ocular measurements for calculating intraocular lens power, monitor epithelium regrowth, and for other ophthalmic measurement evaluations.
Ophthalmic ultrasound imaging system An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.
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FDA Product Code

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Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
IYO System, Imaging, Pulsed Echo, Ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c6121091-b3a5-4f71-ba84-5c269bd49bbc
April 25, 2018
3
August 27, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No CLOSE

Customer Contact

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1-800-223-9044
info@nidek.com
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