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, tomography, computed, emission
510(k) Number K942146
Device Name PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
ROENTGEN ANGIOGRAPHY CHICAGO
2501 N. BARRINGTON ROAD
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact IRENA KRUTULIS
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
ROENTGEN ANGIOGRAPHY CHICAGO
2501 N. BARRINGTON ROAD
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact IRENA KRUTULIS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/03/1994
Decision Date 09/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-