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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K101289
Device Name SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
Applicant
Air Techniques, Inc.
1295 Walt Whitman Rd.
Melville,  NY  11747
Applicant Contact PABLO MARTINEZ
Correspondent
Air Techniques, Inc.
1295 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact PABLO MARTINEZ
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/07/2010
Decision Date 08/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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