Cleared Traditional

K921116 - PX-100 PORTABLE X-RAY GENERATOR

K921116 is an FDA 510(k) clearance for PX-100 PORTABLE X-RAY GENERATOR, manufactured by Acoma Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 210-day FDA review.

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

FDA 510(k) Submission Details - K921116

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.

IZL Device Classification - Class 2, Special Controls

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 155
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K921116.
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K893637 · Shimadzu Medical Systems · Jul 1989