510(k) Report

Devices descending from K070219

35 later devices reach Suniray II Digital Radiography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162585SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc.20161—
+1K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC201113—
+1K090458Dexis SensorDexis, LLC200918—
+2K230732Eagle S/Saevo Slim/D700 SlimAlliage S/A Industrias Medica Odontológico.20230—
+2K210312PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd.20215—
+2K202664Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging20202—
+2K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC201721
+2K163224JAZZ SOLO SensorJazz Imaging, LLC20171—
+2K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC201511—
+2K133206Z-Ray Intra-Oral Digital Radiography SystemZuma Dental, LLC20140—
+2K130088Port View, Digital X-Ray Sensor SystemGenoray Co., Ltd.20130—
+2K102456Intraoral Belsensor GoldTakara Belmont USA, Inc.20111—
+2K112380ClearvisionMidmark Corp.20110—
+3K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…Dental Imaging Technologies Corporation20230—
+3K230998Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited20230—
+3K230811Digital Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited20230—
+3K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging20221—
+3K220422Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd.20221—
+3K213637JAZZ Solo sensorJazz Imaging, LLC Dba Jazz Imaging20210—
+3K212279Digital Intraoral X-ray Imaging SystemIray Technology Taicang, Ltd.20210—
+3K203116SensorXDurr Dental SE20210—
+3K162619I View and Imagen SensorTrident S.R.L20161—
+3K151926QuickRay HD Intraoral SensorDenterprise International, Inc.201510—
+3K123419Eva Select Digital Dental Imaging SystemAfp Imaging Corp.20120—
+4K241649DUO1 and DUO2Zinnovi, Inc.20240—
+4K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC20230—
+4K230916WeSensorPicopack, Inc.20230—
+4K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2Fona S.R.L20210—
+4K211688DC-Air and Athlos-1 and Athlos-AirAthlos OY20210—
+4K200284R-Sensor, R-SensorRemedi Co., Ltd.20200—
+4K181636AuroraSodium Systems, LLC20180—
+4K181358Televere Digital Dental Imaging SystemTelevere Systems, Inc.20180—
+4K163282Apex Dental SensorsMasterlink, LLC20172—
+5K202369RXS 1000Rolence Enterprise, Inc.20210—
+5K190234ODI HD Dental SensorCnd Global Technologies, Inc.20190—