C7 XR IMAGING SYSTEM


Device Classification Name

system, imaging, optical coherence tomography (oct)

510(k) Number K111201
Device Name C7 XR IMAGING SYSTEM
Applicant
LIGHTLAB IMAGING,INC.
one technology park drive
westford, 
MA 
01886

Applicant Contact bryan cowell
Correspondent
LIGHTLAB IMAGING,INC.
one technology park drive
westford, 
MA 
01886

Correspodent Contact bryan cowell
Regulation Number 892.1560
Classification Product Code
NQQ  
Date Received 04/29/2011
Decision Date 08/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No