Get the free K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter - accessdata fda
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This document is a notification from the FDA to Ellex Innovative Imaging, indicating that their device, Eye Cubed Version 4 Diagnostic Ultrasound, is substantially equivalent to legally marketed predicate
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How to fill out k103608 eye cubed version
How to fill out K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter
01
Begin by gathering all necessary patient information, including name, date of birth, and medical record number.
02
Ensure you have the referring physician's details, including their name, contact information, and practice details.
03
Fill in the date of the ultrasound and specify the type of examination being performed.
04
Include detailed clinical information or reasons for the ultrasound, such as symptoms or medical history.
05
Document the physical examination findings relevant to the ultrasound.
06
Clearly outline any relevant prior imaging studies and their findings.
07
Specify the technical details of the ultrasound performed, including equipment used and techniques applied.
08
Provide a summary of findings based on the ultrasound data.
09
Include recommended follow-up actions or additional testing if necessary.
10
Ensure all signatures are collected from the physician and relevant personnel.
Who needs K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter?
01
Patients requiring evaluation of eye conditions such as retinal detachment, tumors, or other ocular diseases.
02
Ophthalmologists needing to document and communicate diagnostic ultrasound findings.
03
Referring physicians who require a detailed report for their patients' medical records.
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People Also Ask about
What is CPT code 92250 for vision?
CPT code 92250 is used to document a diagnostic procedure known as fundus photography. This involves capturing detailed images of the interior surface of the eye, including the retina, optic disc, macula, and posterior pole (the back part of the eye).
What is the CPT code 76705 for ultrasound?
CPT code 76705 is for an ultrasound exam of the abdomen, providing images to assess organs like the liver, kidneys, and pancreas.
What is the CPT code for ultrasound of the eye?
In A-scan, or time-amplitude scan, sound waves are generated at 8 MHz and converted into spikes that correspond with tissue interface zones. In B-scan, or brightness amplitude scan, sound waves are generated at 10 MHz. The data collected by the transducer produces a corresponding image.
What is an eye ultrasound for?
An eye ultrasound is a diagnostic procedure which may be used to test for abnormalities in the eye. The ultrasound helps evaluate the farthest part of the eyeball when there are cataracts. The test may help diagnose retinal detachment or other disorders in the eye, as well as disorders and lesions behind the eye.
What is the difference between CPT code 67005 and 67010?
CPT code 67005 describes manual techniques for removal of vitreous, such as when using a surgical sponge and scissors compared with CPT code 67010 that describes using a mechanical device for removal of the vitreous.
What is the CPT code for eye ultrasound?
76510 (Ophthalmic ultrasound, diagnostic; B-scan and quantitative A-scan performed during the same patient encounter)
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What is K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter?
K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter is a document that provides essential information regarding the specifications and compliance of the Eye Cubed Version 4 diagnostic ultrasound device.
Who is required to file K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter?
Manufacturers or distributors of the Eye Cubed Version 4 diagnostic ultrasound device are required to file the K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter.
How to fill out K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter?
To fill out the K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter, one must provide accurate product information, manufacturer details, and compliance data according to the specified guidelines.
What is the purpose of K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter?
The purpose of the K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter is to ensure that diagnostic ultrasound devices meet regulatory compliance and provide reliable information regarding their usage and safety.
What information must be reported on K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter?
The K103608 Eye Cubed Version 4 Diagnostic Ultrasound Letter must report information such as device specifications, intended use, performance characteristics, and adherence to safety standards.
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