Cleared Traditional

K132165 - QLAB QUANTIFICATION SOFTWARE (FDA 510(k) Clearance)

K132165 · Philips Ultrasound, Inc. · Radiology device

Aug 2013

Decision

28d

Days

Class 2

Risk

K132165 is an FDA 510(k) clearance for the QLAB QUANTIFICATION SOFTWARE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Ultrasound, Inc. (Andover, US). The FDA issued a Cleared decision on August 9, 2013, 28 days after receiving the submission on July 12, 2013.

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

Submission Details

510(k) Number	K132165 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 12, 2013
Decision Date	August 09, 2013
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF