DIGITAL INTEGRATION SYSTEM, DIS2000


the company

Device Classification Name

system, image processing, radiological

510(k) Number K001012
Device Name DIGITAL INTEGRATION SYSTEM, DIS2000
Original Applicant
WELLINGTON MEDICAL SYSTEMS, INC.
19 harvest ave.
dartmouth, 
MA 
02747

Original Contact scott august
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/29/2000
Decision Date 06/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No