Cleared Traditional

K023877 - Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN (FDA 510(k) Clearance)

K023877 · Philips Ultrasound, Inc. · Radiology device

Dec 2002

Decision

32d

Days

Class 2

Risk

K023877 is an FDA 510(k) clearance for the Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN. 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 December 23, 2002, 32 days after receiving the submission on November 21, 2002.

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

Submission Details

510(k) Number	K023877 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 21, 2002
Decision Date	December 23, 2002
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF