Search Results

High resolution ultrasound imaging of wounds such as:

• Clean, closed surgical incisions
• Skin graft donor sites
• Superficial wounds such as abrasion, skin tears, and blisters
• Chafed skin or irritated skin
• Ulcers-cavernous and non-cavernous

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Wounds, Mode of Operation: B

Not Found

This document is a 510(k) premarket notification clearance letter from the FDA for the Hudson 2020/2040/2060 Ultrasound Scanners and their corresponding transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. This is a regulatory pathway for medical devices and does not typically involve the presentation of specific performance studies against acceptance criteria in the same way a de novo or PMA submission might.

Therefore, I cannot extract the requested information about acceptance criteria or a study proving the device meets them from the provided text.

Ask a specific question about this device