510(k) Report

Devices descending from K080582

16 later devices reach Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+1K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+2K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+2K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+3K230918MasterX 800 SeriesMedicatech USA20230—
+3K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+3K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+3K162529DigiX FDXAllengers Medical Systems Limited20176—
+3K140825Delworks DR SystemDel Medical, Inc.20147—
+4K203703I-Q ViewFirst Source, Inc.20210—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K230985Planmeca VisoPlanmeca Oy20233—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—