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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K042894
Device Name IMALUX NIRIS IMAGING SYSTEM
Applicant
IMALUX CORPORATION
1771 EAST 30TH STREET
CLEVELAND,  OH  44114
Applicant Contact STEPHANIE HARRINGTON
Correspondent
IMALUX CORPORATION
1771 EAST 30TH STREET
CLEVELAND,  OH  44114
Correspondent Contact STEPHANIE HARRINGTON
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received10/20/2004
Decision Date 11/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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