Cleared Traditional

K223234 - Delta4 Insight (FDA 510(k) Clearance)

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

K223234 · Scandidos AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
454d
Days
Class 2
Risk

K223234 is an FDA 510(k) clearance for the Delta4 Insight. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Scandidos AB (Uppsala, SE). The FDA issued a Cleared decision on January 16, 2024 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Scandidos AB devices

Submission Details

510(k) Number K223234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2022
Decision Date January 16, 2024
Days to Decision 454 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
347d slower than avg
Panel avg: 107d · This submission: 454d
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 730
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K223234.
VERIQA RT EPID 3D
K252258 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Apr 2026
ClearCheck (RADCC V2.7)
K253962 · Radformation, Inc. · Apr 2026
AlignRT Plus (8.0)
K253012 · Vision Rt, Ltd. · Mar 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026
EMLA (Elekta Evo)
K252188 · Elekta Solutions AB · Jan 2026
ExacTrac Dynamic (2.0.2)
K254010 · Brainlab SE · Jan 2026