Cleared Traditional

K022788 - PHILIPS HARMONY RELEASE 1 (FDA 510(k) Clearance)

K022788 · Philips Medical Systems North America Co. · Radiology device

Oct 2002

Decision

64d

Days

Class 2

Risk

K022788 is an FDA 510(k) clearance for the PHILIPS HARMONY 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 October 25, 2002, 64 days after receiving the submission on August 22, 2002.

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

Submission Details

510(k) Number	K022788 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 22, 2002
Decision Date	October 25, 2002
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF