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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K923619
Device Name ACCULITE SSL
Applicant
Medical Alignment Systems
P.O. Box 21433
3656 Macintosh Ln.
Salt Lake City,  UT  84121
Applicant Contact GEORGE N MCDONALD
Correspondent
Medical Alignment Systems
P.O. Box 21433
3656 Macintosh Ln.
Salt Lake City,  UT  84121
Correspondent Contact GEORGE N MCDONALD
Regulation Number892.5780
Classification Product Code
IWE  
Date Received07/21/1992
Decision Date 11/16/1992
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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