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This document summarizes the premarket notification for the CX50 2.0 Diagnostic Ultrasound System, detailing modifications, indications for use, and regulatory classifications of the ultrasound device.
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How to fill out CX50 2.0 Diagnostic Ultrasound System Premarket Notification
01
Gather all necessary documentation including the device description, intended use, and labeling information.
02
Prepare a comparison table that outlines similarities and differences between the CX50 2.0 and a predicate device.
03
Conduct performance testing to provide data on the CX50 2.0's effectiveness and safety.
04
Compile clinical data and evidence supporting the device's performance claims.
05
Complete the FDA's 510(k) application form accurately.
06
Pay the required application fee.
07
Submit the completed 510(k) application electronically through the FDA's portal.
08
Await feedback or additional requests for information from the FDA.
Who needs CX50 2.0 Diagnostic Ultrasound System Premarket Notification?
01
Healthcare providers looking to acquire the CX50 2.0 for diagnostic purposes.
02
Manufacturers seeking FDA clearance for introducing the CX50 2.0 into the market.
03
Regulatory affairs professionals handling premarket submissions.
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What is CX50 2.0 Diagnostic Ultrasound System Premarket Notification?
The CX50 2.0 Diagnostic Ultrasound System Premarket Notification is a submission made to the FDA to demonstrate that a new or modified medical device is at least as safe and effective as a legally marketed device.
Who is required to file CX50 2.0 Diagnostic Ultrasound System Premarket Notification?
Manufacturers or importers of the CX50 2.0 Diagnostic Ultrasound System who intend to market the device in the United States are required to file the Premarket Notification.
How to fill out CX50 2.0 Diagnostic Ultrasound System Premarket Notification?
To fill out the CX50 2.0 Premarket Notification, manufacturers must provide detailed information about the device, including its intended use, technological characteristics, and data demonstrating substantial equivalence to a predicate device.
What is the purpose of CX50 2.0 Diagnostic Ultrasound System Premarket Notification?
The purpose of the CX50 2.0 Premarket Notification is to obtain FDA clearance to market the device by demonstrating its safety and effectiveness as compared to existing devices.
What information must be reported on CX50 2.0 Diagnostic Ultrasound System Premarket Notification?
The information that must be reported includes device description, intended use, labeling, summary of technological characteristics, and any performance testing results that support the claims of substantial equivalence.
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