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 Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K933777
Device Name CONCEPT ONE
Applicant
Innerscan, Inc.
190 Shepard Ave.
Unit C
Wheeling,  IL  60090
Applicant Contact GARY FROMBERG
Correspondent
Innerscan, Inc.
190 Shepard Ave.
Unit C
Wheeling,  IL  60090
Correspondent Contact GARY FROMBERG
Regulation Number892.1700
Classification Product Code
IZO  
Date Received08/03/1993
Decision Date 12/13/1993
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
-
-