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, X-Ray, Stationary
510(k) Number K183541
Device Name ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
Applicant
Prognosys Medical Systems Private Limited
# 249, Ground Floor, Front Bldg., 4th Main Rd.,
Chamrajpet
Bangalore,  IN 560018
Applicant Contact V. Krishna Prasad
Correspondent
IZiel Healthcare
14, Hadapsar Industrial Estate, Hadapsar
Pune,  IN 411013
Correspondent Contact Shruti Sancheti
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received12/20/2018
Decision Date 01/24/2019
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
-
-