Cleared Traditional

K844549 - HEAD-SPINE STABILIZER HSS-1

K844549 is an FDA 510(k) clearance for HEAD-SPINE STABILIZER HSS-1, manufactured by Imaging Accessories, Inc.. The device is a Class 1 Radiology device with product code IWY cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K844549 · Imaging Accessories, Inc. · Radiology device
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Mar 1985
Decision
100d
Days
Class 1
Risk

K844549 is an FDA 510(k) clearance for the HEAD-SPINE STABILIZER HSS-1. Classified as Holder, Head, Radiographic (product code IWY), Class I - General Controls.

Submitted by Imaging Accessories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1920 - 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 Imaging Accessories, Inc. devices

FDA 510(k) Submission Details - K844549

510(k) Number K844549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date March 01, 1985
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

IWY Device Classification - Class 1, General Controls

Product Code IWY Holder, Head, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1920
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.