• 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, image processing, radiological
510(k) Number K161130
Device Name ResolutionMD
Applicant
CALGARY SCIENTIFIC, INC.
SUITE 208, 1210- 20TH AVENUE SE
calgary,  CA t2g 1m8
Applicant Contact kyle peterson
Correspondent
CALGARY SCIENTIFIC, INC.
SUITE 208, 1210- 20TH AVENUE SE
calgary,  CA t2g 1m8
Correspondent Contact kyle peterson
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/21/2016
Decision Date 08/24/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-