Cleared Traditional

EXCEL CT TWIN (K915738) - FDA 510(k) Clearance

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

K915738 · Elscint, Inc. · Radiology device
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Jul 1992
Decision
214d
Days
Class 2
Risk

K915738 is an FDA 510(k) clearance for the EXCEL CT TWIN. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 214 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 K915738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date July 21, 1992
Days to Decision 214 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
107d slower than avg
Panel avg: 107d · This submission: 214d
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

All 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K915738.
ARM EXTENDER FOR CT TABLES
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SCAN BAND
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SYTEC DENTASCAN
K914305 · General Electric Co. · Feb 1992
CT SYTEC 8000
K913485 · General Electric Co. · Jan 1992
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996 · Siemens Medical Solutions USA, Inc. · Nov 1991