Get the free 510(k) Summary for Diagnostic Ultrasound System sarano - accessdata fda

This document summarizes the regulatory information for the sarano diagnostic ultrasound system, including device classification, intended use, and compliance with safety standards.

How to fill out 510k summary for diagnostic

How to fill out 510(k) Summary for Diagnostic Ultrasound System sarano

1. Gather the necessary product information, including the device name, description, intended use, and indications for use.
2. Provide a comprehensive summary of the device's technological characteristics, including any comparative information to a predicate device.
3. Detail the performance testing data, including safety and effectiveness data that demonstrates the device meets FDA requirements.
4. Include an overview of any biocompatibility testing that was conducted, as applicable.
5. Prepare labeling information, including instructions for use and any relevant warnings or precautions.
6. Summarize the conclusions drawn from the testing and how they support the substantial equivalence to the predicate.
7. Follow the FDA guidelines and format for 510(k) submissions to ensure all necessary information is provided.

Who needs 510(k) Summary for Diagnostic Ultrasound System sarano?

1. Manufacturers of diagnostic ultrasound systems who intend to market their devices in the United States.
2. Companies that seek FDA clearance before launching a new or modified ultrasound device.
3. Entities wishing to ensure compliance with regulatory standards for safety and effectiveness in medical devices.

People Also Ask about

What frequency is used in an ultrasound machine?

Ultrasound probes, called transducers, produce sound waves that have frequencies above the threshold of human hearing (above 20KHz), but most transducers in current use operate at much higher frequencies (in the megahertz (MHz) range).

What is the ultrasonic frequency range?

Is ultrasound audible? Sounds with a frequency of 20 kHz and higher are referred to as ultrasound (or ultrasonic sound). High frequency sound is sound of which the frequency lies between 8 and 20 kHz.

What is the Hz on ultrasound?

The ultrasound machine records the reflected sound waves and the resulting patterns generate a visual image of a person's internal organs and tissues. The typical frequency of ultrasound waves is between 2 MHz and 15 MHz. Frequencies that are higher produce a shorter wavelength and increased attenuation.

What is the 510k pathway?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the range of frequencies associated ultrasound?

Answer: (a) Range of frequencies associated with infrasound : 1 Hz to 20 Hz. (b) Range of frequencies associated with ultrasound : 2 x 104 Hz to 1010 Hz.

What is diagnostic ultrasound frequency range?

Typical medical ultrasound frequencies are between 2 MHz < ξ < 40 Mhz. Traditionally, medical ultrasound is mainly put to use in diagnostic applications, however, more therapeutic applications are emerging.

What is the 510k summary?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

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What is 510(k) Summary for Diagnostic Ultrasound System sarano?

The 510(k) Summary for Diagnostic Ultrasound System Sarano is a document submitted to the FDA that demonstrates that the device is substantially equivalent to an already legally marketed device. It includes details regarding the device's intended use, technology, and performance.

Who is required to file 510(k) Summary for Diagnostic Ultrasound System sarano?

Manufacturers of the Diagnostic Ultrasound System Sarano or companies that wish to market the device are required to file a 510(k) Summary with the FDA to gain market clearance.

How to fill out 510(k) Summary for Diagnostic Ultrasound System sarano?

To fill out the 510(k) Summary for the Diagnostic Ultrasound System Sarano, manufacturers must complete a standardized form outlining device identification, intended use, comparison to predicate devices, and provide results from performance testing and clinical data if applicable.

What is the purpose of 510(k) Summary for Diagnostic Ultrasound System sarano?

The purpose of the 510(k) Summary for the Diagnostic Ultrasound System Sarano is to assure the FDA that the device is as safe and effective as existing devices, thereby facilitating its approval for commercial distribution.

What information must be reported on 510(k) Summary for Diagnostic Ultrasound System sarano?

The 510(k) Summary must report device name, intended use, description of the device, comparison to comparable devices, manufacturing information, and data on safety and effectiveness, including any testing results.