Varian Clinac 1800S
FDA 510(k) K882326 · Varian Assoc., Inc.
510(k) numberK882326
Submission
- Device name
- Varian Clinac 1800S
- Applicant
- Varian Assoc., Inc.
Palo Alto, CA, US - Received
- June 6, 1988
- Decision date
- September 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K000922 | Proton VisionMUJ · Traditional | 05/24/2000SE |
| K992762 | Brachyvision 6.0MUJ · Traditional | 03/09/2000SE |
| K992751 | SomavisionKPQ · Traditional | 02/16/2000SE |
| K992753 | Cadplan Plus: 3D Treatment Planning SystemMUJ · Special | 09/03/1999SE |
| K990085 | Millennium MLC -120IYE · Special | 02/08/1999SE |
| K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…JAQ · Traditional | 10/21/1998SE |
| K955844 | Applicators for Varian Varisource Remote High Dose Rate AfterloaderJAQ · Traditional | 07/26/1996SE |
| K955774 | Varis PortalvisionIYE · Traditional | 03/15/1996SE |
| K954467 | Cadplan BTJAQ · Traditional | 03/15/1996SE |
| K943224 | Varian Multileaf CollimatorIYE · Traditional | 02/02/1996SE |
Questions and answers
When was Varian Clinac 1800S cleared by the FDA?
Varian Clinac 1800S (K882326) received a 510(k) decision of Substantially Equivalent on September 19, 1988, 105 days after the submission was received.
What is the product code of K882326?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.