Cleared Traditional

K913352 - C-150 ULTRAFAST CT SCANNER

K913352 is an FDA 510(k) clearance for C-150 ULTRAFAST CT SCANNER, manufactured by Imatron, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K913352 · Imatron, Inc. · Radiology device
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Nov 1991
Decision
126d
Days
Class 2
Risk

K913352 is an FDA 510(k) clearance for the C-150 ULTRAFAST CT SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Imatron, Inc. (South San Fransisco, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 126 days - within the typical 510(k) review window.

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 Imatron, Inc. devices

FDA 510(k) Submission Details - K913352

510(k) Number K913352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1991
Decision Date November 29, 1991
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 714
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K913352.
SYTEC DENTASCAN
K914305 · General Electric Co. · Feb 1992
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CT SYTEC 8000
K913485 · General Electric Co. · Jan 1992
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
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GYROVIEW-HR
K913029 · Philips Medical Systems, Inc. · Oct 1991
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K912454 · Eastman Kodak Company · Sep 1991