Encompass SRS Headframe ; Encompass MR SRS Headframe
FDA 510(k) K182189 · Qfix
510(k) numberK182189
Submission
- Device name
- Encompass SRS Headframe ; Encompass MR SRS Headframe
- Applicant
- Qfix
Avondale, PA, US - Received
- August 13, 2018
- Decision date
- October 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | Radformation, Inc. | 08/31/2026SE |
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | Manteia Technologies Co., Ltd. | 08/26/2026SE |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 08/03/2026SE |
| K252937 | ThinkQA 3IYE · Traditional | Dosisoft SA | 06/12/2026SE |
| K253004 | Luna 3DIYE · Traditional | Lap GmbH Laser Applikationen | 06/04/2026SE |
| K260792 | AerFrame Patient Immobilization System (AFPIS)IYE · Traditional | Stabilix, LLC | 05/08/2026SE |
| K252258 | Veriqa RT Epid 3DIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten… | 04/15/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | Radformation, Inc. | 04/03/2026SE |
| K253012 | AlignRT Plus (8.0)IYE · Traditional | Vision Rt, Ltd. | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 01/21/2026SE |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K230312 | Iris AirShuttleIYE · Special | 03/31/2023SE |
| K193243 | Alta Multipurpose DeviceIYE · Traditional | 02/28/2020SE |
| K190668 | Encompass 15 Channel Head Coil, 3TMOS · Traditional | 09/09/2019SE |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesIYE · Traditional | 07/11/2017SE |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer…IYE · Traditional | 06/14/2016SE |
| K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass…IYE · Traditional | 12/04/2015SE |
Questions and answers
When was Encompass SRS Headframe ; Encompass MR SRS Headframe cleared by the FDA?
Encompass SRS Headframe ; Encompass MR SRS Headframe (K182189) received a 510(k) decision of Substantially Equivalent on October 4, 2018, 52 days after the submission was received.
What is the product code of K182189?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.