MRGP OPTICAL TRACKING UNIT

Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K991943
Device Name MRGP OPTICAL TRACKING UNIT
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
highland heights, 
OH 
44143

Applicant Contact elaine k keeler
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
highland heights, 
OH 
44143

Correspodent Contact elaine k keeler
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 06/09/1999
Decision Date 08/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No