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 Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K253296
Device Name Digital C-ARM with 3D
Applicant
Allengers Medical Systems Limited
Fda Hall, Unit-2,
Bhankarpur, Mubarakpur Rd., Derabassi, Distt Mohali
Sas Nagar Mohali,  IN 140507
Applicant Contact Sanjeev K. Marjara
Correspondent
Allengers Medical Systems Limited
Fda Hall, Unit-2,
Bhankarpur, Mubarakpur Rd., Derabassi, Distt Mohali
Sas Nagar Mohali,  IN 140507
Correspondent Contact Sanjeev K. Marjara
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received09/29/2025
Decision Date 06/05/2026
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
-
-