Cleared Traditional

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM (K881305) - FDA 510(k) Clearance

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

K881305 · Toshiba Medical Systems · Radiology device
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Oct 1988
Decision
205d
Days
Class 2
Risk

K881305 is an FDA 510(k) clearance for the TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM. 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 October 19, 1988 after a review of 205 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba Medical Systems devices

Submission Details

510(k) Number K881305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date October 19, 1988
Days to Decision 205 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 107d · This submission: 205d
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 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K881305.
TCT-300S - UPGRADE
K900233 · Toshiba America Medical Systems, In.C · Feb 1990
CT HILIGHT ADVANTAGE
K894269 · GE Medical Systems · Sep 1989
CT SYTEC 3000
K893820 · General Electric Co. · Aug 1989
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · Philips Medical Systems (Cleveland), Inc. · Oct 1988
CT MAX 640 #B7940 JA/JE
K882581 · General Electric Co. · Aug 1988
XENON CT
K875088 · Siemens Medical Solutions USA, Inc. · Jul 1988