Cleared Traditional

PX-100 PORTABLE X-RAY GENERATOR (K921116) - FDA 510(k) Clearance

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

K921116 · Acoma Medical Imaging, Inc. · Radiology device
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Oct 1992
Decision
210d
Days
Class 2
Risk

K921116 is an FDA 510(k) clearance for the PX-100 PORTABLE X-RAY GENERATOR. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 210 days - an extended review cycle.

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 Acoma Medical Imaging, Inc. devices

Submission Details

510(k) Number K921116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date October 05, 1992
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
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

All 95
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