Cleared Traditional

K031836 - PHILIPS FRESCO RELEASE 1 (FDA 510(k) Clearance)

K031836 · Philips Medical Systems North America Co. · Radiology device

Aug 2003

Decision

62d

Days

Class 2

Risk

K031836 is an FDA 510(k) clearance for the PHILIPS FRESCO RELEASE 1. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on August 14, 2003, 62 days after receiving the submission on June 13, 2003.

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

Submission Details

510(k) Number	K031836 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 13, 2003
Decision Date	August 14, 2003
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF