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 Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K082450
Device Name IDR
Applicant
ICRCO INC.
2580 WEST 237TH STREET
TORRANCE,  CA  90505
Applicant Contact THOMAS CHANEY
Correspondent
ICRCO INC.
2580 WEST 237TH STREET
TORRANCE,  CA  90505
Correspondent Contact THOMAS CHANEY
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/25/2008
Decision Date 06/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-