• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name system, digital image communications, radiological
510(k) Number K954479
Device Name DICOMVIEW
Original Applicant
HEARTLAB, INC.
146 westminster st.
suite 500
providence,  RI  02903
Original Contact richard petrocelli
Regulation Number892.2020
Classification Product Code
LMD  
Date Received09/26/1995
Decision Date 02/21/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-