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, Tomography, Computed, Emission
510(k) Number K212004
Device Name MyoSPECT, MyoSpect ES
Applicant
Ge Healthcare
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Applicant Contact George Mashour
Correspondent
Ge Healthcare
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Correspondent Contact George Mashour
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/28/2021
Decision Date 08/27/2021
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
Recalls CDRH Recalls
-
-