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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K943532
Device Name PANORAMIC CORPORATION HDLX
Applicant
Panoramic Corp.
4321 Goshen Rd.
Ft. Wayne,  IN  46818
Applicant Contact MARK SMITH
Correspondent
Panoramic Corp.
4321 Goshen Rd.
Ft. Wayne,  IN  46818
Correspondent Contact MARK SMITH
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/21/1994
Decision Date 12/07/1994
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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