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, Tomography, Computed
510(k) Number K241440
Device Name HealthCCSng
Applicant
Nano-X AI Ltd.
Shlomo Shmeltzer Road 94
PO BOX 3486
Petah Tikva,  IL 4970602
Applicant Contact Neta Sherman
Correspondent
Nano-X AI Ltd.
Shlomo Shmeltzer Road 94
PO BOX 3486
Petah Tikva,  IL 4970602
Correspondent Contact Neta Sherman
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/21/2024
Decision Date 08/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-