Cleared Traditional

HISPEED NX/I CT SCANNER SYSTEM (K991716) - FDA 510(k) Clearance

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

K991716 · Ge Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
29d
Days
Class 2
Risk

K991716 is an FDA 510(k) clearance for the HISPEED NX/I CT SCANNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 18, 1999 after a review of 29 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 Ge Medical Systems, Inc. devices

Submission Details

510(k) Number K991716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1999
Decision Date June 18, 1999
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 430
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K991716.
ULTRASIM CT SYSTEM
K001088 · Philips Medical Systems (Cleveland), Inc. · Jun 2000
SOMATOM PROJECT 10-CT SCANNERS
K991764 · Siemens Medical Solutions USA, Inc. · Aug 1999
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
K991766 · Toshiba America Medical Systems, In.C · Aug 1999
CALCIUM SCORING
K990426 · Siemens Medical Solutions USA, Inc. · May 1999
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)
K990134 · Toshiba America Medical Systems, In.C · Mar 1999
FACTS
K982010 · Philips Medical Systems (Cleveland), Inc. · Nov 1998