Cleared Traditional

K991766 - ECG-GATING SYSTEM FOR AQUILION CT SCANNER

K991766 is the FDA 510(k) clearance for ECG-GATING SYSTEM FOR AQUILION CT SCANNER by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K991766 · Toshiba America Medical Systems, In.C · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
78d
Days
Class 2
Risk

K991766 is an FDA 510(k) clearance for the ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 78 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K991766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date August 10, 1999
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K991766.
CT PERFUSION OPTION
K993791 · Ge Medical Systems, Inc. · Nov 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · Ge Medical Systems, Inc. · Nov 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764 · Siemens Medical Solutions USA, Inc. · Aug 1999
HISPEED NX/I CT SCANNER SYSTEM
K991716 · Ge Medical Systems, Inc. · Jun 1999
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K991600 · Siemens Corp. · Jun 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
K991553 · Shimadzu Corp. · Jun 1999