HEARTNAVIGATOR RELEASE 1


Device Classification Name

system, image processing, radiological

510(k) Number K111245
Device Name HEARTNAVIGATOR RELEASE 1
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
22100 bothell everett highway
bothell, 
WA 
98021 -8431

Applicant Contact lynn harmer
Correspondent
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
22100 bothell everett highway
bothell, 
WA 
98021 -8431

Correspodent Contact lynn harmer
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/03/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No