Illumeo System

FDA 510(k) K173588 · Philips Medical Systems Technologies , Ltd.

Substantially Equivalent

510(k) numberK173588

Submission

Device name
Illumeo System
Applicant
Philips Medical Systems Technologies , Ltd.
Haifa, IL
Received
November 20, 2017
Decision date
January 12, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 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 Illumeo System cleared by the FDA?

Illumeo System (K173588) received a 510(k) decision of Substantially Equivalent on January 12, 2018, 53 days after the submission was received.

What is the product code of K173588?

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