Cleared Traditional

K953482 - XKNIFE-3

K953482 is an FDA 510(k) clearance for XKNIFE-3, manufactured by Radionics Software Applications, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K953482 · Radionics Software Applications, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
93d
Days
Class 2
Risk

K953482 is an FDA 510(k) clearance for the XKNIFE-3. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Radionics Software Applications, Inc. (Burlington, US). The FDA issued a Cleared decision on October 25, 1995 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K953482

510(k) Number K953482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1995
Decision Date October 25, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 704
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K953482.
EXL-15DP & 20-DP LINAC
K952108 · Mitsubishi Intl. Corp. · Dec 1995
PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM
K954165 · Ptw-New York Corp. · Dec 1995
PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)
K940001 · Nucletron Corp. · Nov 1995
PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
K953570 · Philips Medical Systems, Inc. · Oct 1995
UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR
K951764 · Ptw-New York Corp. · Oct 1995
PERI-PUSHER
K953046 · Diacor, Inc. · Sep 1995
K953482 · XKNIFE-3
Download PDF FDA Summary Radionics Software Ap…