XKNIFE 5— 510(k) K100417

Substantially Equivalent

Integra Radionics, Inc.

FDA 510(k) clearance K100417 for XKNIFE 5, Substantially Equivalent on 2010-04-08. Applicant: Integra Radionics, Inc.. Device class: 2.

Clearance details

Applicant: Integra Radionics, Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2010-02-16
Decision date: 2010-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUJ

K260750 — Virtual Cone (1.0)2026-07-08
K253050 — RadOncAI2026-06-18
K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
K252784 — eXaSkin Plus2026-05-22
K253078 — ART.1-US2026-05-14

More clearances from Integra Radionics, Inc.

K102258 — CUSA NXT EXTENDED LENGTH TIP2011-06-10
K100096 — LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART2010-04-22
K090864 — CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM2009-05-08
K083414 — RADIONICS XKNIFE HDRT SYSTEM2009-03-02
K081459 — CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM2008-08-13

Recalls naming K100417

K-number listed on FDA's recall record

Z-1103-2013 — Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.Class II·Terminated·Integra LifeSciences Corp.·20121210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100417.

Data sourced from openFDA. This site is unofficial and independent of the FDA.