Cleared Traditional

K900170 - MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900170 · Elscint, Inc. · Radiology device
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Jul 1990
Decision
194d
Days
Class 2
Risk

K900170 is an FDA 510(k) clearance for the MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Elscint, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on July 25, 1990 after a review of 194 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Elscint, Inc. devices

Submission Details

510(k) Number K900170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1990
Decision Date July 25, 1990
Days to Decision 194 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 107d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

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