Xknife 5
FDA 510(k) K100417 · Integra Radionics, Inc.
510(k) numberK100417
Submission
- Device name
- Xknife 5
- Applicant
- Integra Radionics, Inc.
Burlington, MA, US - Received
- February 16, 2010
- Decision date
- April 8, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code MUJ
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|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 510(k) | Device | Decision |
|---|---|---|
| K102258 | Cusa NXT Extended Length TipLFL · Traditional | 06/10/2011SE |
| K100096 | Linac Collimator Assembly Housing (Lcah) Model LcahartIYE · Traditional | 04/22/2010SE |
| K090864 | Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemLFL · Traditional | 05/08/2009SE |
| K083414 | Radionics Xknife HDRT SystemMUJ · Traditional | 03/02/2009SE |
| K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation SystemLFL · Traditional | 08/13/2008SE |
| K072454 | Integra Radionics Interfix Patient AdaptersIYE · Traditional | 10/16/2007SE |
| K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone TipLFL · Traditional | 08/17/2007SE |
| K063230 | Integra Radionics Imagefusion 3MUJ · Special | 12/21/2006SE |
| K061893 | Integra Radionics Xknife RT 4MUJ · Special | 07/25/2006SE |
Questions and answers
When was Xknife 5 cleared by the FDA?
Xknife 5 (K100417) received a 510(k) decision of Substantially Equivalent on April 8, 2010, 51 days after the submission was received.
What is the product code of K100417?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.