Cleared Traditional

K152321 - kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening

K152321 is an FDA 510(k) clearance for kVue Encompass SRS Insert (Encompass In..., manufactured by Qfix. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K152321 · Qfix · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
109d
Days
Class 2
Risk

K152321 is an FDA 510(k) clearance for the kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encom.... Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Qfix (Avondale, US). The FDA issued a Cleared decision on December 4, 2015 after a review of 109 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 Qfix devices

FDA 510(k) Submission Details - K152321

510(k) Number K152321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2015
Decision Date December 04, 2015
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
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

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