Cleared Traditional

K183606 - Delta4 Phantom+ MR (PMMA)

K183606 is an FDA 510(k) clearance for Delta4 Phantom+ MR (PMMA), manufactured by Scandidos AB. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K183606 · Scandidos AB · Radiology device
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Apr 2019
Decision
103d
Days
Class 2
Risk

K183606 is an FDA 510(k) clearance for the Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW). 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 April 8, 2019 after a review of 103 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 Scandidos AB devices

FDA 510(k) Submission Details - K183606

510(k) Number K183606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date April 08, 2019
Days to Decision 103 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
4d faster than avg
Panel avg: 107d · This submission: 103d
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 333
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K183606.
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