FDA 510(k) Applications Submitted by Lynn Allman
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250099 |
01/14/2025 |
Mobius3D (4.1) |
Varian Medical Systems |
| K250289 |
01/31/2025 |
Intracavitary/Interstitial System |
Varian Medical Systems |
| K250299 |
01/31/2025 |
CT/ MR Tandem and Ovoid Set |
Varian Medical Systems, Inc. |
| K240480 |
02/20/2024 |
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBla |
Varian Medical Systems, Inc. |
| K240784 |
03/21/2024 |
Temperature Sensor Probe (ABL-18TP20) |
Varian Medical Systems, Inc. |
| K241386 |
05/15/2024 |
Heyman Packing Applicator Set (GM11004580) |
Varian Medical Systems, Inc. |
| K241764 |
06/20/2024 |
Mould Probe MR Safe |
Varian Medical Systems, Inc. |
| K241853 |
06/27/2024 |
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve |
Varian Medical Systems, Inc. |
| K241876 |
06/28/2024 |
Vitesse (5.0) |
Varian Medical Systems |
| K241965 |
07/03/2024 |
Catheter Surface Flap Applicator Set (GM11011830) |
Varian Medical Systems |
| K242378 |
08/09/2024 |
Eclipse Treatment Planning System (18.1) |
Varian Medical Systems |
| K232400 |
08/10/2023 |
VariSeed (v10) |
Varian Medical Systems |
| K232623 |
08/29/2023 |
Universal Endometrial Applicator Set (GM11009840) |
Varian Medical Systems Inc. |
| K242608 |
09/03/2024 |
Embozene Color-Advanced Microspheres |
Varian Medical Systems, Inc. |
| K232870 |
09/15/2023 |
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) |
Varian Medical Systems, Inc |
| K242794 |
09/16/2024 |
ONCOZENE Microspheres |
Varian Medical Systems, Inc. |
| K232923 |
09/19/2023 |
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) |
Varian Medical Systems Inc. |
| K242957 |
09/25/2024 |
Identify (4.0) |
Varian Medical Systems, Inc. |
| K242961 |
09/25/2024 |
Intraluminal Applicator Set |
Varian Medical Systems |
| K243939 |
12/20/2024 |
Titanium Flexible Geometry FSD Applicator Set (GM11013400) |
Varian Medical Systems, Inc. |
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