• 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, mammographic
510(k) Number K123414
Device Name SPECBOARD JR.
Applicant
MACBRUD CORP., MEDICAL DIVISION
14021 SW 143 COURT, UNIT 6
miami,  FL  33186
Applicant Contact todd lary
Correspondent
MACBRUD CORP., MEDICAL DIVISION
14021 SW 143 COURT, UNIT 6
miami,  FL  33186
Correspondent Contact todd lary
  View current 510(K) holder
Current 510(k) Holder *
MACBRUD CORP., MEDICAL DIVISION
12101 SW 131 Avenue
miami,  FL  33186
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/06/2012
Decision Date 01/11/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No

 
* Reported through Establishment Registration and Device Listing
-
-