Cleared Traditional

K962010 - EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS (FDA 510(k) Clearance)

K962010 · Philips Medical Systems (Cleveland), Inc. · Radiology device

Mar 1997

Decision

302d

Days

Class 2

Risk

K962010 is an FDA 510(k) clearance for the EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on March 21, 1997, 302 days after receiving the submission on May 23, 1996.

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

Submission Details

510(k) Number	K962010 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 23, 1996
Decision Date	March 21, 1997
Days to Decision	302 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF