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, Mobile
510(k) Number K221081
Device Name iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
Applicant
First Source, Inc.
3495 Winton Pl., Bldg. E, Suite 1
Rochester,  NY  14623
Applicant Contact Ronald Viola
Correspondent
Medmonts Co., Ltd.
Life Officetel 320, 40, 63-Ro, Youngdeungpo-Gu
Seoul,  KR 07345
Correspondent Contact Woo Sung Park
Regulation Number892.1720
Classification Product Code
IZL  
Date Received04/12/2022
Decision Date 06/13/2022
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
Recalls CDRH Recalls
-
-