UroNav System

FDA 510(k) K193403 · Invivo Corporation

Substantially Equivalent

510(k) numberK193403

Submission

Device name
UroNav System
Applicant
Invivo Corporation
Florida, FL, US
Received
December 6, 2019
Decision date
December 27, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was UroNav System cleared by the FDA?

UroNav System (K193403) received a 510(k) decision of Substantially Equivalent on December 27, 2019, 21 days after the submission was received.

What is the product code of K193403?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.