Cleared Traditional

K982787 - ASTEION CT SCANNER

K982787 is the FDA 510(k) clearance for ASTEION 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 72-day FDA review.

K982787 · Toshiba America Medical Systems, In.C · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
72d
Days
Class 2
Risk

K982787 is an FDA 510(k) clearance for the ASTEION CT SCANNER, TSX-021A. 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 October 21, 1998 after a review of 72 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 K982787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date October 21, 1998
Days to Decision 72 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
35d faster than avg
Panel avg: 107d · This submission: 72d
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 K982787.
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K982536 · Siemens Corp. · Nov 1998
FACTS
K982010 · Philips Medical Systems (Cleveland), Inc. · Nov 1998
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SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
K982583 · Shimadzu Corp. · Oct 1998
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
K982349 · Siemens Medical Solutions USA, Inc. · Sep 1998