510(k) Report

Devices descending from K992660

130 later devices reach Urf Digital - OT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+6K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+6K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+6K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+6K233543YSIO X.preeSiemens Medical Solutions20241—
+6K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+6K231995AcuityUDRRadmedix, LLC20230—
+6K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+6K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+6K212336Soteria.AIOmega Medical Imaging, LLC20211—
+6K210307Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20211—
+6K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+6K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+6K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+6K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+6K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+7K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+7K250738YSIO X.preeSiemens Medical Solutions20250—
+7K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+7K223409Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20220—
+7K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+8K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+9K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+9K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+10K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+10K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+10K233532MULTIX Impact ESiemens Medical Solutions20230—