FDA 510(k) Applications Submitted by Peter J. Coronado

FDA 510(k) Number Submission Date Device Name Applicant
K211881 06/21/2021 AI Segmentation Varian Medical Systems, Inc.
K231863 06/23/2023 ProBeam 360░ Proton Therapy System v2.0 (Multiroom) Varian Medical Systems, Inc.
K203469 11/25/2020 AI Segmentation Varian Medical Systems, Inc.
K161540 06/03/2016 Advanced Breast Template System VARIAN MEDICAL SYSTEMS, INC.
K230271 01/31/2023 ISOLIS Cryoprobe Varian Medical Systems, Inc.
K130251 02/01/2013 ESOPHAGUS BOUGIE SET VARIAN MEDICAL SYSTEMS, INC.
K140528 03/04/2014 TRUE BEAM, TRUE BEAM STX, EDGE VARIAN MEDICAL SYSTEMS, INC.
K141248 05/14/2014 SMART SEGMENTATION KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC.
K141283 05/16/2014 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K141336 05/21/2014 SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS VARIAN MEDICAL SYSTEMS, INC.
K141490 06/05/2014 UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET VARIAN MEDICAL SYSTEMS, INC.
K141624 06/17/2014 PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 VARIAN MEDICAL SYSTEMS, INC.
K131807 06/19/2013 HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS, INC.
K131891 06/25/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K132705 08/29/2013 UNIQUE VARIAN MEDICAL SYSTEMS, INC.
K192377 08/30/2019 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon Varian Medical Systems, Inc.
K142560 09/11/2014 Varian Head Frame VARIAN MEDICAL SYSTEMS, INC.
K133227 10/21/2013 SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC.
K133240 10/21/2013 VARIAN MULTILEAF COLLIMATOR VARIAN MEDICAL SYSTEMS, INC.
K133247 10/22/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K192968 10/23/2019 IDENTIFY Varian Medical Systems, Inc.
K133331 10/29/2013 4D INTEGRATED TREATMENT CONSOLE VARIAN MEDICAL SYSTEMS, INC.
K133572 11/20/2013 ARIA RADIATION THERAPY MANAGEMENT VARIAN MEDICAL SYSTEMS, INC.
K123788 12/10/2012 INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) VARIAN MEDICAL SYSTEMS, INC.
K123815 12/12/2012 SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE VARIAN MEDICAL SYSTEMS, INC.
K124002 12/26/2012 VERIFICATION CONSOLE VARIAN MEDICAL SYSTEMS
K160021 01/05/2016 Varian Sterilization Boxes VARIAN MEDICAL SYSTEMS, INC.
K160045 01/08/2016 Heyman Packing Applicator Set VARIAN MEDICAL SYSTEMS, INC
K190137 01/29/2019 Identify Varian Medical Systems Inc.
K160516 02/24/2016 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths Varian Medical Systems, Inc
K230557 02/28/2023 Eclipse Treatment Planning System (v18.0) Varian Medical Systems, Inc.
K230576 03/01/2023 IDENTIFY Varian Medical Systems Inc.
K180586 03/05/2018 Varian Head Frame Varian Medical Systems, Inc.
K200608 03/09/2020 Eclipse Treatment Planning System v16.0 Varian Medical Systems, Inc.
K150636 03/11/2015 VariSeed 9.0 VARIAN MEDICAL SYSTEMS, INC.
K230699 03/13/2023 ARIA Radiation Therapy Management (v18.0) Varian Medical Systems Inc.
K150706 03/18/2015 VitalBeam VARIAN MEDICAL SYSTEMS, INC.
K170817 03/20/2017 Halcyon Varian Medical Systems Inc.
K210835 03/22/2021 Identify Varian Medical Systems Inc.
K160815 03/24/2016 Interstitial Needles VARIAN MEDICAL SYSTEMS, INC.
K150839 03/30/2015 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 VARIAN MEDICAL SYSTEMS, INC.
K170969 03/31/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc.
K151022 04/16/2015 Intraluminal Applicator Set VARIAN MEDICAL SYSTEMS, INC.
K181032 04/18/2018 Halcyon Varian Medical Systems Inc.
K211149 04/19/2021 Urethral Warming Catheter Kit Varian Medical Systems, Inc.
K181145 05/01/2018 Eclipse Treatment Planning System Varian Medical Systems, Inc.
K231317 05/08/2023 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc.
K221408 05/16/2022 ARIA Radiation Therapy Management (v16.1 MR3) Varian Medical Systems, Inc
K221448 05/18/2022 ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) Varian Medical Systems, Inc
K181404 05/29/2018 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Varian Medical Systems, Inc.
K171631 06/02/2017 Standard Catheter Set Varian Medical Systems, Inc.
K161576 06/07/2016 Esophagus Bougie Set Varian Medical Systems, Inc.
K151533 06/08/2015 Respiratory Gating for Scanners VARIAN MEDICAL SYSTEMS, INC
K201588 06/12/2020 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice Varian Medical Systems, Inc.
K191580 06/14/2019 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device Varian Medical Systems, Inc.
K201607 06/15/2020 Eclipse Treatment Planning System v16.1 Varian Medical Systems, Inc
K151657 06/19/2015 Shielded Applicator Set, Cervical Stop VARIAN MEDICAL SYSTEMS, INC
K221791 06/21/2022 ProBeam 360░ Proton Therapy System Varian Medical Systems, Inc.
K221797 06/21/2022 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device Varian Medical Systems Inc.
K191761 07/01/2019 Mobius3D Varian Medical Systems, Inc
K172013 07/03/2017 VitalBeam Varian Medical Systems, Inc.
K151882 07/09/2015 Varian Treatment (VTx) VARIAN MEDICAL SYSTEMS, INC.
K162018 07/14/2016 Surface Applicator Set Varian Medical Systems, Inc.
K181903 07/16/2018 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device Varian Medical Systems, Inc.
K172163 07/18/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc.
K152018 07/21/2015 Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets VARIAN MEDICAL SYSTEMS, INC.
K212294 07/22/2021 Ethos Treatment Management, Ethos Treatment Planning Varian Medical Systems, Inc.
K142268 08/15/2014 Varian Verification System (VVS) VARIAN MEDICAL SYSTEMS, INC.
K172533 08/22/2017 GM Implant Tubes, Length Cutting Gauge Varian Medical Systems, Inc.
K152393 08/24/2015 Eclipse Treatment Planning System VARIAN MEDICAL SYSTEMS, INC.
K172611 08/31/2017 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths Varian Medical Systems, Inc
K172675 09/05/2017 Varian Cervical Sleeves Varian Medical Systems, Inc.
K192424 09/05/2019 Mobius3D Varian Medical Systems, Inc
K162476 09/06/2016 Varian High Energy Linear Accelerator Varian Medical Systems, Inc.
K162472 09/06/2016 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc.
K162533 09/09/2016 Kelowna GYN and Crook Prostate Templates Varian Medical Systems, Inc
K222775 09/14/2022 Aarhus Applicator Set Varian Medical Systems, Inc
K162615 09/19/2016 Mould Applicator Set Varian Medical Systems, Inc
K222941 09/26/2022 Halcyon, Ethos Radiotherapy System Varian Medical Systems, Inc
K143224 11/10/2014 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc.
K173636 11/24/2017 Velocity Varian Medical Systems, Inc.
K193240 11/25/2019 Universal Cylinder Applicator Family Varian Medical Systems, Inc.
K203669 12/16/2020 Mobius3D Varian Medical Systems, Inc.
K213927 12/16/2021 Respiratory Gating for Scanners v2.0 Varian Medical Systems, Inc.
K173838 12/18/2017 ARIA Radiation Therapy Management Varian Medical Systems, Inc.
K213977 12/20/2021 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc.
K223839 12/22/2022 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc.
K203766 12/23/2020 4D Integrated Treatment Console Varian Medical Systems, Inc.


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