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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K828562
Device Name DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE
Applicant
Digirad Corp.
1047 Elwell Ct.
Palo Alto,  CA  94303
Correspondent
Digirad Corp.
1047 Elwell Ct.
Palo Alto,  CA  94303
Date Received11/16/1982
Decision Date 04/28/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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