Cleared Traditional

HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS (K980169) - FDA 510(k) Clearance

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

K980169 · General Electric Co. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
87d
Days
Class 2
Risk

K980169 is an FDA 510(k) clearance for the HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on April 13, 1998 after a review of 87 days - a notably fast clearance 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: 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 General Electric Co. devices

Submission Details

510(k) Number K980169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date April 13, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 351
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K980169.
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
K982349 · Siemens Medical Solutions USA, Inc. · Sep 1998
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
K982004 · General Electric Co. · Aug 1998
PINPOINT
K974513 · Philips Medical Systems (Cleveland), Inc. · May 1998
HISPEED QX/I CT SCANNER SYSTEM
K980176 · General Electric Co. · Apr 1998
FLY THROUGH
K971717 · Siemens Medical Solutions USA, Inc. · Sep 1997
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
K971054 · Siemens Medical Solutions USA, Inc. · Jun 1997