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 K913471
Device Name CIRRUS GAMMA CAMERA
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact LARRY HERNANDEZ
Correspondent
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Correspondent Contact LARRY HERNANDEZ
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/05/1991
Decision Date 10/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-