Collaboration Live

FDA 510(k) K200179 · Philips Health Care

Substantially Equivalent

510(k) numberK200179

Submission

Device name
Collaboration Live
Applicant
Philips Health Care
Bothell, WA, US
Received
January 24, 2020
Decision date
February 18, 2020
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 Collaboration Live cleared by the FDA?

Collaboration Live (K200179) received a 510(k) decision of Substantially Equivalent on February 18, 2020, 25 days after the submission was received.

What is the product code of K200179?

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