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 Interventional Fluoroscopic X-Ray System
510(k) Number K222998
Device Name F3
Applicant
Acrew Imaging, Inc.
38852 Cedar Waxwing Ln.
Ocean View,  DE  19970
Applicant Contact Craig Hughes
Correspondent
Yolanda Smith
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number892.1650
Classification Product Code
OWB  
Date Received09/28/2022
Decision Date 06/20/2023
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
-
-