FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text is a 510(k) summary for the SOPRO S-57 Video Imaging System and a letter from the FDA determining substantial equivalence. This document does not contain any information about acceptance criteria, the results of a study to prove they are met, or details about device performance metrics, sample sizes, expert involvement, or ground truth establishment.

The 510(k) summary primarily focuses on demonstrating substantial equivalence to pre-existing devices based on design, technology, specifications, and intended use. It largely asserts that the S-57 is "virtually identical" to other marketed devices.

Therefore, I cannot provide the requested information based on the input text.

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K Number

K962024

Device Name

S-57 VIDEO IMAGING SYSTEM

Manufacturer

DEL MEDICAL SYSTEMS CORP.

Date Cleared

1996-07-09

(47 days)