Cleared Traditional

K973908 - AUKLET CT SCANNER

K973908 is the FDA 510(k) clearance for AUKLET 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 69-day FDA review.

K973908 · Toshiba America Medical Systems, In.C · Radiology device
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Dec 1997
Decision
69d
Days
Class 2
Risk

K973908 is an FDA 510(k) clearance for the AUKLET CT SCANNER, TSX-003A. 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 December 22, 1997 after a review of 69 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 K973908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date December 22, 1997
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
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 K973908.
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
K980169 · General Electric Co. · Apr 1998
HISPEED QX/I CT SCANNER SYSTEM
K980176 · General Electric Co. · Apr 1998
ANATOM 1000 (A MINUS, A-)
K974455 · Analogic Corp. · Feb 1998
SMARTVIEW OPTIONS FOR HISPEED CT/I
K973168 · GE Medical Systems · Nov 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · Shimadzu Medical Systems · Oct 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · Shimadzu Medical Systems · Oct 1997