Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K042894
Device Name IMALUX NIRIS IMAGING SYSTEM
Applicant
Imalux Corporation
1771 E. 30th St.
Cleveland,  OH  44114
Applicant Contact STEPHANIE HARRINGTON
Correspondent
Imalux Corporation
1771 E. 30th St.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-