Cleared Traditional

K924828 - BI-N

K924828 is an FDA 510(k) clearance for BI-N, manufactured by Xre Corp.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K924828 · Xre Corp. · Radiology device
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Dec 1992
Decision
80d
Days
Class 2
Risk

K924828 is an FDA 510(k) clearance for the BI-N. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Xre Corp. (Littleton, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Xre Corp. devices

FDA 510(k) Submission Details - K924828

510(k) Number K924828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date December 17, 1992
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 126
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K924828.
ANCOR
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K924137 · Fischer Imaging Corp. · Dec 1992
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K922222 · Siemens Medical Solutions USA, Inc. · Dec 1992
POLY DIAGNOST CDX
K923654 · Xre Corp. · Nov 1992
PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION
K923813 · Philips Medical Systems, Inc. · Oct 1992