Cleared Traditional

K911500 - SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH

K911500 is an FDA 510(k) clearance for SHIMADZU WHOLE BODY X-RAY CT SCANNER SC..., manufactured by Shimadzu Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K911500 · Shimadzu Medical Systems · Radiology device
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Jul 1991
Decision
105d
Days
Class 2
Risk

K911500 is an FDA 510(k) clearance for the SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH. 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 July 17, 1991 after a review of 105 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

FDA 510(k) Submission Details - K911500

510(k) Number K911500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date July 17, 1991
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
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 736
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K911500.
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LITEBOX
K913252 · Siemens Gammasonics, Inc. · Aug 1991
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
K911501 · Shimadzu Medical Systems · Jul 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859 · Siemens Medical Solutions USA, Inc. · May 1991
CT SYTEC 4000
K911387 · GE Medical Systems · May 1991