HI-RES 9000 PHASED ARRAY CAROTID COIL


information about

Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K001210
Device Name HI-RES 9000 PHASED ARRAY CAROTID COIL
Original Applicant
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Original Contact rony thomas
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 04/14/2000
Decision Date 06/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No