SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K072541
Device Name SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
Applicant
SENORX, INC.
11 columbia
aliso viejo, 
CA 
92656

Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO   KNW  
Date Received 09/10/2007
Decision Date 09/25/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No