510(k) · Radiology

SIS Software Version 3.6.0

by Surgical Information Sciences, Inc.

SIS Software Version 3.6.0 is an AI-enabled medical device from Surgical Information Sciences, Inc. that the U.S. FDA cleared through 510(k) K192304 on September 13, 2019. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2019, all FDA AI clearances in 2019, top radiology AI devices.

Key facts

Submission numberK192304
Pathway510(k)
Date of final decision
Company (FDA list)Surgical Information Sciences, Inc.
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Surgical Information Sciences, Inc.
Applicant locationPlymouth, MN, US
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. SIS Software Version 3.6.0 went through this pathway (K192304).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #56 of 161 under that code. Surgical Information Sciences, Inc. has 7 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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