• 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 K162011
Device Name MedDream
Applicant
SOFTNETA UAB
K.BARAUSKO STR. 59
kaunas,  LT 51423
Applicant Contact laura baroniene
Correspondent
LICENSALE INC
57 LAZY BROOK RD
monroe,  CT  06468
Correspondent Contact raymond kelly
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/21/2016
Decision Date 10/14/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-