LUNG NODULE ASSESSMENT AND COMPARISON OPTION


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K023785
Device Name LUNG NODULE ASSESSMENT AND COMPARISON OPTION
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland, 
OH 
44143

Original Contact robert l turocy
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 11/12/2002
Decision Date 02/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No