Cleared Traditional

K933299 - QL MULTIPULSE 2048

K933299 is an FDA 510(k) clearance for QL MULTIPULSE 2048, manufactured by Infimed, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K933299 · Infimed, Inc. · Radiology device
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Nov 1993
Decision
119d
Days
Class 2
Risk

K933299 is an FDA 510(k) clearance for the QL MULTIPULSE 2048. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Infimed, Inc. (Liverpool, US). The FDA issued a Cleared decision on November 3, 1993 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Infimed, Inc. devices

FDA 510(k) Submission Details - K933299

510(k) Number K933299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1993
Decision Date November 03, 1993
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 158
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