3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING


information about

Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K002807
Device Name 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
Original Applicant
ACUSON CORP.
1220 charleston rd.
mountain view, 
CA 
94039 -7393

Original Contact chalon green
Regulation Number 892.1560
Classification Product Code
IYO  
Date Received 09/08/2000
Decision Date 12/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No