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 K981553
Device Name AUTOMATED MEDICAL REPORT WRITER
Applicant
Woodson and Associates, LLC
2476 Burnt Leaf Ln.
Decatur,  GA  30033
Applicant Contact GRATTAN WOODSON, III
Correspondent
Woodson and Associates, LLC
2476 Burnt Leaf Ln.
Decatur,  GA  30033
Correspondent Contact GRATTAN WOODSON, III
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/01/1998
Decision Date 09/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-