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 Processor, Radiographic-Film, Automatic
510(k) Number K024342
Device Name RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
Applicant
Daito Co., Ltd.
945 Main St.
Suite 312
Manchester,  CT  06040
Applicant Contact EDWARD EPSTEIN
Correspondent
Daito Co., Ltd.
945 Main St.
Suite 312
Manchester,  CT  06040
Correspondent Contact EDWARD EPSTEIN
Regulation Number892.1900
Classification Product Code
IXW  
Date Received12/27/2002
Decision Date 04/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-