Cleared Traditional

K113748 - IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

K113748 is an FDA 510(k) clearance for IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD), manufactured by Imris, Inc.. The device is a Class 2 Radiology device with product code HBL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K113748 · Imris, Inc. · Radiology device
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Mar 2012
Decision
93d
Days
Class 2
Risk

K113748 is an FDA 510(k) clearance for the IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD). Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Imris, Inc. (Winnipeg, Mb, CA). The FDA issued a Cleared decision on March 23, 2012 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.4460 - 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 Imris, Inc. devices

FDA 510(k) Submission Details - K113748

510(k) Number K113748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date March 23, 2012
Days to Decision 93 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
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 - HBL Holder, Head, Neurosurgical (skull Clamp)

All 33
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K113748.
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