NM APPLICATION SUITE


Device Classification Name

system, image processing, radiological

510(k) Number K080961
Device Name NM APPLICATION SUITE
Applicant
PHILIPS NUCLEAR MEDICINE, INC
540 alder dr.
milpitas, 
CA 
95035

Applicant Contact lori r peterson
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/04/2008
Decision Date 04/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls