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 Interventional Fluoroscopic X-Ray System
510(k) Number K173639
Device Name Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
Applicant
Siemens Medi Cal Solutions, Inc.
40 Liberty Blvd., 65-1a
Malvern,  PA  19355
Applicant Contact Denise Adams
Correspondent
Siemens Medi Cal Solutions, Inc.
40 Liberty Blvd., 65-1a
Malvern,  PA  19355
Correspondent Contact Denise Adams
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received11/24/2017
Decision Date 04/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-