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, Image Processing, Radiological
510(k) Number K251880
Device Name Archy Dental Imaging
Applicant
Archy Dental, Inc.
3031 Tisch Way, 110 Plaza W.
San Jose,  CA  95128
Applicant Contact Benjamin Kolin Kolin
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/18/2025
Decision Date 11/21/2025
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
-
-