MRGFUS PELVIC PA COIL MODEL 1.0


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K111060
Device Name MRGFUS PELVIC PA COIL MODEL 1.0
Applicant
INSIGHTECH, LTD
5 nahum heth st.
tirat carmel, 

IL

39120

Applicant Contact ori lubin
Correspondent
INSIGHTECH, LTD
5 nahum heth st.
tirat carmel, 

IL

39120

Correspodent Contact ori lubin
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 04/18/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No