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 K171560
Device Name OTIS Optical Coherence Tomography System
Applicant
Perimeter Medical Imaging, Inc.
47 Colborne St.
Suite 202
Toronto,  CA M5E 1P8
Applicant Contact Elizabeth Munro
Correspondent
Perimeter Medical Imaging, Inc.
47 Colborne St.
Suite 202
Toronto,  CA M5E 1P8
Correspondent Contact Elizabeth Munro
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received05/30/2017
Decision Date 08/25/2017
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-