Cleared Traditional

XVI R4.5 (K100115) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100115 · Elekta , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
54d
Days
Class 2
Risk

K100115 is an FDA 510(k) clearance for the XVI R4.5. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Elekta , Ltd. (Crawley W. Sussex, GB). The FDA issued a Cleared decision on March 10, 2010 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elekta , Ltd. devices

Submission Details

510(k) Number K100115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2010
Decision Date March 10, 2010
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 165
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K100115.
ARTISTETM SOLUTION WITH SYS VCIO
K121295 · Siemens Medical Solutions USA, Inc. · Jun 2012
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
K103606 · Siemens Medical Solutions USA, Inc. · Apr 2011
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
K102671 · Siemens Medical Solutions USA, Inc. · Oct 2010
160MLC OPTION
K092145 · Siemens Medical Solutions USA, Inc. · Sep 2009
SYNGO RT THERAPIST CONNECT
K090683 · Siemens Medical Solutions USA, Inc. · May 2009
PRESCISION OPTION
K082775 · Siemens Medical Solutions USA, Inc. · Feb 2009