Cleared Traditional

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (K151426) - FDA 510(k) Clearance

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

K151426 · Scandidos AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
246d
Days
Class 2
Risk

K151426 is an FDA 510(k) clearance for the ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+. 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 29, 2016 after a review of 246 days - an extended review 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: 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 Scandidos AB devices

Submission Details

510(k) Number K151426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date January 29, 2016
Days to Decision 246 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
139d slower than avg
Panel avg: 107d · This submission: 246d
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 228
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K151426.
Halcyon
K170817 · Varian Medical Systems, Inc. · Jun 2017
TrueBeam-TrueBeam STx-Edge
K162472 · Varian Medical Systems, Inc. · Jan 2017
Varian High Energy Linear Accelerator
K162476 · Varian Medical Systems, Inc. · Dec 2016
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
K152761 · Varian Medical Systems, Inc. · Nov 2015
Varian Treatment (VTx)
K151882 · Varian Medical Systems, Inc. · Oct 2015
VitalBeam
K150706 · Varian Medical Systems, Inc. · May 2015