Cleared Traditional

K894887 - SHIMADZU WHOLE BODY X-RAY CT SCANNER SC...

K894887 is the FDA 510(k) clearance for SHIMADZU WHOLE BODY X-RAY CT SCANNER SC... by Shimadzu Medical Systems. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K894887 · Shimadzu Medical Systems · Radiology device
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Dec 1989
Decision
135d
Days
Class 2
Risk

K894887 is an FDA 510(k) clearance for the SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on December 14, 1989 after a review of 135 days - within the typical 510(k) review window.

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 Shimadzu Medical Systems devices

Submission Details

510(k) Number K894887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date December 14, 1989
Days to Decision 135 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
28d slower than avg
Panel avg: 107d · This submission: 135d
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 K894887.
TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
K896456 · Toshiba America Medical Systems, In.C · Mar 1990
TCT-300S - UPGRADE
K900233 · Toshiba America Medical Systems, In.C · Feb 1990
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
K894888 · Shimadzu Medical Systems · Jan 1990
ELSCINT'S EXEL 2400E CT SCANNER
K894542 · Elscint, Inc. · Sep 1989
CT HILIGHT ADVANTAGE
K894269 · GE Medical Systems · Sep 1989
CT SYTEC 3000
K893820 · General Electric Co. · Aug 1989