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 K223311
Device Name Philips CT 3500
Applicant
Philips Healthcare (Suzhou) Co., Ltd
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Xu Diana
Correspondent
Philips Healthcare (Suzhou) Co., Ltd
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Xu Diana
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/28/2022
Decision Date 12/22/2022
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
-
-