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 Accelerator, Linear, Medical
510(k) Number K952314
Device Name EXL-12SP & 12DP LINAC
Applicant
Mitsubishi Intl. Corp.
Two Tower Bridge
1 Fayette St., Suite 100
Conshohocken,  PA  19428
Applicant Contact HIDEYUIKI H KAWAKAMI
Correspondent
Mitsubishi Intl. Corp.
Two Tower Bridge
1 Fayette St., Suite 100
Conshohocken,  PA  19428
Correspondent Contact HIDEYUIKI H KAWAKAMI
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/17/1995
Decision Date 01/17/1996
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
-
-