MSK EXTREME MR SCANNER, MODEL AA5000


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K080048
Device Name MSK EXTREME MR SCANNER, MODEL AA5000
Applicant
ONI MEDICAL SYSTEMS, INC.
301 ballardvale st.
suite 4
wilmington, 
MA 
01887

Applicant Contact mark puopolo
Correspondent
ONI MEDICAL SYSTEMS, INC.
301 ballardvale st.
suite 4
wilmington, 
MA 
01887

Correspodent Contact mark puopolo
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 01/08/2008
Decision Date 02/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls