PRIMELUNG


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K024149
Device Name PRIMELUNG
Original Applicant
ACCUIMAGE DIAGNOSTICS CORP.
400 grandview dr.
south san francisco, 
CA 
94080

Original Contact oscar g carbo
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 12/16/2002
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No