AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE


Device Classification Name

cassette, radiographic film

510(k) Number K023020
Device Name AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
Original Applicant
AGFA CORP.
10 south academy st.
greenville, 
SC 
29601

Original Contact pamela k gwynn
Regulation Number 892.1850
Classification Product Code
IXA  
Date Received 09/11/2002
Decision Date 09/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls