Cleared Traditional

K791317 - IREX REAL TIME PHASED ARRAY SYSTEM

K791317 is an FDA 510(k) clearance for IREX REAL TIME PHASED ARRAY SYSTEM, manufactured by Irex Corp.. The device is a Class 2 Radiology device with product code CDP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K791317 · Irex Corp. · Radiology device
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Sep 1979
Decision
67d
Days
Class 2
Risk

K791317 is an FDA 510(k) clearance for the IREX REAL TIME PHASED ARRAY SYSTEM. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Irex Corp. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.1710 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Irex Corp. devices

FDA 510(k) Submission Details - K791317

510(k) Number K791317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date September 17, 1979
Days to Decision 67 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 119
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K791317.
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VENTRE/SEP T3 TEST SET
K791588 · Ventrex Laboratories, Inc. · Sep 1979
DAC-CEL T3
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K790960 · Bio-Rad · Aug 1979
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K790908 · Ventrex Laboratories, Inc. · Jun 1979