Cleared Traditional

K201665 - Collaboration Live (FDA 510(k) Clearance)

K201665 · Philips Ultrasound, Inc. · Radiology device

Sep 2020

Decision

88d

Days

Class 2

Risk

K201665 is an FDA 510(k) clearance for the Collaboration Live. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Ultrasound, Inc. (Bothell, US). The FDA issued a Cleared decision on September 15, 2020, 88 days after receiving the submission on June 19, 2020.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K201665 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 2020
Decision Date	September 15, 2020
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF