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 K940487
Device Name ISOCAM II (DUAL HEAD GAMMA CAMERA)
Applicant
Independent Scintilation Imaging Systems, Inc.
3195 Louis A Amos
Lachine Quebec,  CA H8T 1C4
Applicant Contact PETER SCHULTZ
Correspondent
Independent Scintilation Imaging Systems, Inc.
3195 Louis A Amos
Lachine Quebec,  CA H8T 1C4
Correspondent Contact PETER SCHULTZ
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/03/1994
Decision Date 09/30/1994
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
-
-