ENDOSCOUT TRACKING SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K111226
Device Name ENDOSCOUT TRACKING SYSTEM
Applicant
ROBIN MEDICAL, INC.
56b shadowbrook drive
hudson, 
NH 
03051

Applicant Contact raymond kelly
Correspondent
ROBIN MEDICAL, INC.
56b shadowbrook drive
hudson, 
NH 
03051

Correspodent Contact raymond kelly
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 05/02/2011
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No