PICA WHOLE-BODY MRI SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K110942
Device Name PICA WHOLE-BODY MRI SYSTEM
Applicant
TIME MEDICAL LIMITED
no. 2 science park west ave.
shatin, nt
hong kong, 

CN

ch

Applicant Contact john baby
Correspondent
TIME MEDICAL LIMITED
no. 2 science park west ave.
shatin, nt
hong kong, 

CN

ch

Correspodent Contact john baby
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 04/04/2011
Decision Date 07/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No