Cleared Traditional

K853444 - TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT...

K853444 is an FDA 510(k) clearance for TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT..., manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K853444 · Toshiba Medical Systems · Radiology device
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Nov 1985
Decision
84d
Days
Class 2
Risk

K853444 is an FDA 510(k) clearance for the TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on November 8, 1985 after a review of 84 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 Medical Systems devices

FDA 510(k) Submission Details - K853444

510(k) Number K853444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date November 08, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 608
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K853444.
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