Devices descending from K050438
944 later devices reach Stealthstation System Update through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K161119 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | 4 | — |
| +6 | K160258 | X5 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | 2 | — |
| +6 | K160420 | SpeqT | Signostics Limited | 2016 | 1 | — |
| +6 | K152854 | S50 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | 16 | — |
| +7 | K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/… | Esonic Technology (Wuhan) Co., Ltd. | 2026 | 0 | — |
| +7 | K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | 0 | — |
| +7 | K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026 | 0 | — |
| +7 | K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026 | 0 | — |
| +7 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update… | Stryker Leibinger GmbH & Co KG | 2026 | 0 | — |
| +7 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | 2 | — |
| +7 | K252557 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2025 | 0 | — |
| +7 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | 2 | — |
| +7 | K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | 2025 | 0 | — |
| +7 | K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025 | 0 | — |
| +7 | K251639 | xvision Spine system | Augmedics, Ltd. | 2025 | 1 | — |
| +7 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | 4 | — |
| +7 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | 0 | — |
| +7 | K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025 | 0 | — |
| +7 | K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025 | 1 | — |
| +7 | K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | 2025 | 0 | — |
| +7 | K243975 | Knee+ | Pixee Medical | 2025 | 3 | — |
| +7 | K243838 | NEXXT MATRIXX® SI System | Nexxt Spine | 2025 | 0 | — |
| +7 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | Alphatec Spine | 2025 | 3 | — |
| +7 | K243835 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024 | 0 | — |
| +7 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | 4 | — |
| +7 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | 2024 | 1 | — |
| +7 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | 2 | — |
| +7 | K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 | 7 | — |
| +7 | K242009 | 360CAS Knee | Kico Knee Innovation Company Pty, Ltd. | 2024 | 0 | — |
| +7 | K241083 | SIS System | Surgical Information Sciences, Inc. | 2024 | 1 | — |
| +7 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | 7 | — |
| +7 | K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System… | SeaSpine Orthopedics Corporation | 2024 | 1 | 2 |
| +7 | K234030 | Clear Guide SCENERGY | Clear Guide Medical | 2024 | 0 | — |
| +7 | K233734 | Interson USB Ultrasound System | Interson Corporation | 2023 | 0 | — |
| +7 | K231354 | Pocket Ultrasound System (C10) | Beijing Konted Medical Technology Co.,Ltd | 2023 | 2 | — |
| +7 | K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023 | 4 | 1 |
| +7 | K232500 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2023 | 0 | 1 |
| +7 | K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | 2023 | 1 | 1 |
| +7 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | 11 | — |
| +7 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 7 | 1 |
| +7 | K230066 | Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co., Ltd. | 2023 | 0 | — |
| +7 | K231799 | INERTIA® CONNEXX™ Modular Pedicle Screw System | Nexxt Spine, LLC | 2023 | 0 | — |
| +7 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | 7 | — |
| +7 | K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023 | 0 | — |
| +7 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | 7 | — |
| +7 | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | 20 | — |
| +7 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | 0 | — |
| +7 | K211987 | ATEC Alignment App | Alphatec Spine, Inc. | 2021 | 2 | — |
| +7 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | 2021 | 17 | — |
| +7 | K211300 | X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | 2021 | 3 | — |
| +7 | K211299 | X-CUBE 70 | Alpinion Medical Systems Co., Ltd. | 2021 | 3 | — |
| +7 | K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC… | Supersonic Imagine | 2021 | 2 | — |
| +7 | K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | 2 | — |
| +7 | K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc… | Supersonic Imagine | 2020 | 0 | — |
| +7 | K202737 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and… | Canon Medical Systems Corporation | 2020 | 0 | — |
| +7 | K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020 | 7 | — |
| +7 | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | 5 | Class I |
| +7 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | 9 | — |
| +7 | K200001 | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 8 | — |
| +7 | K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | 8 | — |
| +7 | K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020 | 24 | 3 |
| +7 | K192170 | VistaScan USB Ultrasound Imaging System | Emagine Solutions Technology, LLC | 2020 | 0 | — |
| +7 | K192410 | ZS3 and z.one pro Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 3 | — |
| +7 | K192152 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 6 | — |
| +7 | K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 | 4 | — |
| +7 | K192573 | Dolphin Medical Imaging USB Ultrasound System | Dolphin Medical Imaging, LLC | 2019 | 0 | — |
| +7 | K192435 | NuVasive NuvaLine | Nu Vasive, Incorporated | 2019 | 0 | — |
| +7 | K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019 | 31 | 5 |
| +7 | K190206 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 0 | — |
| +7 | K183191 | 6420 Ultrasound System | Esaote, S.p.A. | 2018 | 0 | — |
| +7 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7… | Philips Ultrasound, Inc. | 2018 | 19 | 23 |
| +7 | K182427 | Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2018 | 4 | — |
| +7 | K182679 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 | Canon Medical Systems Corporation | 2018 | 10 | — |
| +7 | K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | 2018 | 1 | — |
| +7 | K181574 | Uscan | EchoNous, Inc. | 2018 | 0 | — |
| +7 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | 2 | — |
| +7 | K173138 | Biim Diagnostic Ultrasound System | Biim Ultrasound AS | 2017 | 0 | — |
| +7 | K170085 | SONON Ultrasound Imaging System, Model: 300L | Healcerion Co., Ltd. | 2017 | 4 | — |
| +7 | K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017 | 22 | — |
| +7 | K163510 | Poseidon Ultrasound System | Butterfly Network, Inc. | 2017 | 6 | 2 |
| +7 | K170303 | E5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017 | 0 | — |
| +7 | K163427 | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017 | 0 | — |
| +7 | K162288 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | 3 | — |
| +7 | K160283 | S45 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | 15 | — |
| +8 | K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026 | 0 | — |
| +8 | K261854 | xvision Spine system | Augmedics, Ltd. | 2026 | 0 | — |
| +8 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer… | SeaSpine Orthopedics Corporation | 2026 | 0 | — |
| +8 | K253216 | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | 2026 | 0 | — |
| +8 | K253805 | Knee+ | Pixee Medical S.A.S. | 2026 | 0 | — |
| +8 | K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025 | 0 | — |
| +8 | K251820 | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | — |
| +8 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025 | 0 | — |
| +8 | K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025 | 0 | — |
| +8 | K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025 | 0 | — |
| +8 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | 1 | — |
| +8 | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote, S.p.A. | 2025 | 2 | — |
| +8 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025 | 0 | — |
| +8 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2025 | 2 | — |
| +8 | K242519 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2025 | 0 | Class I |
| +8 | K242670 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2025 | 0 | Class I |