Cleared Traditional

K941363 - PHANTOM

K941363 is an FDA 510(k) clearance for PHANTOM, manufactured by Dynarad Corp.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K941363 · Dynarad Corp. · Radiology device
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Jul 1994
Decision
121d
Days
Class 2
Risk

K941363 is an FDA 510(k) clearance for the PHANTOM. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 121 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 Dynarad Corp. devices

FDA 510(k) Submission Details - K941363

510(k) Number K941363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date July 20, 1994
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
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
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