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 full field digital, system, x-ray, mammographic
510(k) Number K121963
Device Name PLANMED NUANCE DIGIGUIDE
Applicant
PLANMED OY
ASENTAJANKATU 6
SORVAAJANKATU 7
HELSINKI,  FI FI-00880
Applicant Contact LARS MORING
Correspondent
PLANMED OY
ASENTAJANKATU 6
SORVAAJANKATU 7
HELSINKI,  FI FI-00880
Correspondent Contact LARS MORING
Regulation Number892.1715
Classification Product Code
MUE  
Date Received07/05/2012
Decision Date 11/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-