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This document serves as a premarket notification to demonstrate that the Aplio MX (vI.0) SSA-780A Ultrasound System is substantially equivalent to existing devices. It details the device's features,
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How to fill out 510k premarket notification apliotm
How to fill out 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System
01
Gather necessary documentation including device description, intended use, and labeling.
02
Identify and provide the predicate device information for the AplioTM MX (vl.0) SSA-780A.
03
Prepare a summary of performance testing, including non-clinical and clinical data if applicable.
04
Complete the required FDA forms, including Form 3514 for the 510(k) submission.
05
Compile the administrative paperwork such as establishment registration and device listing.
06
Review and ensure all information is accurate and complies with FDA requirements.
07
Submit the complete 510(k) application electronically via FDA’s submissions portal.
08
Pay the appropriate user fee, if required, for the 510(k) submission.
Who needs 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System?
01
Manufacturers of the AplioTM MX (vl.0) SSA-780A Ultrasound System who intend to market their device in the United States.
02
Healthcare facilities or organizations that wish to utilize the AplioTM MX for diagnostic and therapeutic ultrasound procedures requiring FDA clearance.
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What is 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System?
The 510(k) Premarket Notification for the AplioTM MX (vl.0) SSA-780A Ultrasound System is a submission made to the FDA to demonstrate that this ultrasound device is safe and effective and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System?
Manufacturers or importers of the AplioTM MX (vl.0) SSA-780A Ultrasound System are required to file a 510(k) Premarket Notification with the FDA prior to marketing the device.
How to fill out 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System?
To fill out the 510(k) Premarket Notification for the AplioTM MX (vl.0) SSA-780A Ultrasound System, manufacturers must complete the FDA's 510(k) application form, provide device descriptions, comparisons to predicate devices, intended use, labeling, and performance data.
What is the purpose of 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System?
The purpose of the 510(k) Premarket Notification for the AplioTM MX (vl.0) SSA-780A Ultrasound System is to secure FDA clearance to market a new device by demonstrating that it is safe and effective for its intended use.
What information must be reported on 510(k) Premarket Notification AplioTM MX (vl.0) SSA-780A Ultrasound System?
The 510(k) Premarket Notification must report details such as the device name, manufacturer information, intended use, technological characteristics, labeling, and any summary of safety and effectiveness data.
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