1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K111673
Device Name 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
Applicant
INVIVO CORPORATION
3545 s.w. 47th ave.
gainesville, 
FL 
32608

Applicant Contact elizabeth wheeler
Correspondent
INVIVO CORPORATION
3545 s.w. 47th ave.
gainesville, 
FL 
32608

Correspodent Contact elizabeth wheeler
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 06/15/2011
Decision Date 12/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No