nCommand Lite System

FDA 510(k) K233660 · Ionic Health

Substantially Equivalent

510(k) numberK233660

Submission

Device name
nCommand Lite System
Applicant
Ionic Health
São José Dos Campos/Sp, BR
Received
November 15, 2023
Decision date
March 18, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 nCommand Lite System cleared by the FDA?

nCommand Lite System (K233660) received a 510(k) decision of Substantially Equivalent on March 18, 2024, 124 days after the submission was received.

What is the product code of K233660?

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