Cleared Traditional

K003437 - ODYSSEY LX, MODEL 211320 (FDA 510(k) Clearance)

K003437 · Philips Medical Systems (Cleveland), Inc. · Radiology device

Feb 2001

Decision

88d

Days

Class 2

Risk

K003437 is an FDA 510(k) clearance for the ODYSSEY LX, MODEL 211320. 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 February 2, 2001, 88 days after receiving the submission on November 6, 2000.

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

Submission Details

510(k) Number	K003437 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 06, 2000
Decision Date	February 02, 2001
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF