510(k) Report

Devices descending from K973598

168 later devices reach Siremobil CO2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+5K173878PreXion3D ExcelsiorPrexion Corporation20181—
+5K163423Orthopantomograph OP300Palodex Group OY201721
+5K160140DENTRIa seriesHdx Will Corp.20169—
+5K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+5K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy20167—
+5K123332Naomi-CTLk Consulting Group20130—
+5K130443I-Max Touch 3DOwandy201321
+5K130297Scanora 3DXPalodex Group OY20130—
+5K122981Rayscan a-Expert 3DRay Co., Ltd.201324—
+5K122806Image Works PanouraMic International20132—
+5K122018OP300Palodex Group OY20128—
+5K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+6K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+6K252068MC2 Portable X-ray SystemOxos Medical202501
+6K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+6K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+6K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+6K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+6K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+6K213278Planmed VerityPlanmed OY20220—
+6K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+6K212336Soteria.AIOmega Medical Imaging, LLC20211—
+6K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+6K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+6K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+6K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+6K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+6K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A.20181—
+6K181576Planmeca VisoPlanmeca Oy20184—
+6K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+6K181136CS 9600Trophy201811
+6K160525RCT700Ray Co., Ltd.201611—
+6K142247Rayscan a-Expert 3DRay Co., Ltd.201522—
+6K133544OP300Palodex Group OY20147—
+6K131695Rayscan a-Expert 3DRay Co., Ltd.201323—
+6K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+7K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+7K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+7K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+7K200183CS 9600Trophy202001
+7K182614RCT700Ray Co., Ltd.20186—
+7K181452RCT800Ray Co., Ltd.201810—
+7K180947Orthopantomograph OP 3DPalodex Group OY201821
+7K171012Veraview X800J. Morita USA, Inc.20171—
+7K170813Orthopantomograph OP 3DPalodex Group OY201701
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K213226RCT700Ray Co., Ltd.20215—
+8K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+8K182805RCT800Ray Co., Ltd.20188—
+9K251798RCT700Ray Co., Ltd.20250—
+9K243903RCT600Ray Co., Ltd.20250—
+9K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.20250—
+9K230753RCT800Ray Co., Ltd.20231—
+9K192737RCT800Ray Co., Ltd.20197—
+10K260462RCT800Ray Co., Ltd.20260—
+10K222219R2 Studio Q/RCT820Megagen Implant Co., Ltd.20220—