Cleared Traditional

K223209 - Elekta Unity

K223209 is an FDA 510(k) clearance for Elekta Unity, manufactured by Elekta Solutions AB. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K223209 · Elekta Solutions AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
129d
Days
Class 2
Risk

K223209 is an FDA 510(k) clearance for the Elekta Unity. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on February 23, 2023 after a review of 129 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.

View all Elekta Solutions AB devices

FDA 510(k) Submission Details - K223209

510(k) Number K223209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2022
Decision Date February 23, 2023
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
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 331
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K223209.
ExacTrac Dynamic 1.1.2
K231052 · Brainlab AG · May 2023
ARIA Radiation Therapy Management (v18.0)
K230699 · Varian Medical Systems, Inc. · Apr 2023
Iris AirShuttle™
K230312 · Qfix · Mar 2023
MOSAIQ® OIS (Oncology Information System)
K223229 · Elekta Solutions AB · Feb 2023
DSPS-Prominent™ Masks
K222977 · Macromedics BV · Feb 2023
Halcyon, Ethos Radiotherapy System
K222941 · Varian Medical Systems, Inc. · Jan 2023