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, Image Processing, Radiological
510(k) Number K941093
Device Name SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION
Applicant
Smartpacs
1026 Carmel Dr.
Simi Valley,  CA  93065
Applicant Contact MARK MITCHELL
Correspondent
Smartpacs
1026 Carmel Dr.
Simi Valley,  CA  93065
Correspondent Contact MARK MITCHELL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/1994
Decision Date 11/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-