• 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 radiological computer-assisted triage and notification software
510(k) Number K182177
Device Name Accipiolx
Applicant
MaxQ-Al Ltd.
76 Yigal Alon Street, 5th Floor
tel aviv,  IL 6706701
Applicant Contact joshua schulman
Correspondent
MaxQ-Al Ltd.
76 Yigal Alon Street, 5th Floor
tel aviv,  IL 6706701
Correspondent Contact joshua schulman
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/10/2018
Decision Date 10/26/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-