Medicatech USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)May 16, 2025
K230918MasterX 800 SeriesSeptember 1, 2023
K190601MasteRad MX30April 25, 2019
K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemFebruary 6, 2015
K130377KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMMay 17, 2013
K112132KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMNovember 18, 2011
K102284KRYSTALRAD 560 (FLAATZ 560)January 3, 2011
K102285KRYSTALRAD (ATAL8)January 3, 2011
K082798DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000October 28, 2008
K080582MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FAMay 15, 2008