Cleared Traditional

ACU-RAY HF SERIES PORTABLE X-RAY UNIT (K972204) - FDA 510(k) Clearance

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

K972204 · Sterne Equipment Co., Ltd. · Radiology device
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Oct 1997
Decision
118d
Days
Class 2
Risk

K972204 is an FDA 510(k) clearance for the ACU-RAY HF SERIES PORTABLE X-RAY UNIT. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sterne Equipment Co., Ltd. (Brampton, On., CA). The FDA issued a Cleared decision on October 8, 1997 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Sterne Equipment Co., Ltd. devices

Submission Details

510(k) Number K972204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1997
Decision Date October 08, 1997
Days to Decision 118 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

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