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, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K250331
Device Name Astrasono A3Pro Bladder Scanner (A3Pro)
Applicant
Astrasono Technology Co., Ltd.
1417 Honghai Bldg. # 1372 Qianhai Rd., Xiangnan Commun
Nanshan St., Nanshan District
Shenzhen,  CN 518107
Applicant Contact Charles Shen
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received02/05/2025
Decision Date 09/30/2025
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
-
-