DIAGNOSTIC ULTRASOUND, MODEL 1.0


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K992378
Device Name DIAGNOSTIC ULTRASOUND, MODEL 1.0
Applicant
VOLUMETRICS MEDICAL IMAGING, INC.
700 main st.
durham, 
NC 
27701

Applicant Contact jim mundell
Correspondent
VOLUMETRICS MEDICAL IMAGING, INC.
700 main st.
durham, 
NC 
27701

Correspodent Contact jim mundell
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 07/16/1999
Decision Date 09/29/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
statement

statement

Type Traditional
Reviewed by Third Party No
Combination Product

No