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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K860776
Device Name MATRIX LR, LR 22A & LR/LASER RECORDER
Applicant
Matrix Instruments
Agfa Corp.
One Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact ROY F CAMPBELL
Correspondent
Matrix Instruments
Agfa Corp.
One Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact ROY F CAMPBELL
Regulation Number892.2040
Classification Product Code
LMC  
Date Received03/03/1986
Decision Date 06/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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