Cleared Traditional

K874767 - SHIMADZU WHOLE BODY X-RAY CT SCANNER SC...

K874767 is an FDA 510(k) clearance for SHIMADZU WHOLE BODY X-RAY CT SCANNER SC..., manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K874767 · Shimadzu Precision Instruments, Inc. · Radiology device
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Feb 1988
Decision
98d
Days
Class 2
Risk

K874767 is an FDA 510(k) clearance for the SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on February 25, 1988 after a review of 98 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 Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K874767

510(k) Number K874767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date February 25, 1988
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
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 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K874767.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
K875370 · Shimadzu Precision Instruments, Inc. · May 1988
PICS-2000
K880822 · Philips Medical Systems, Inc. · Mar 1988
SOMATOM PLUS
K880965 · Siemens Medical Solutions USA, Inc. · Mar 1988
CT PACE CATALOG NUMBER B7950A
K872526 · General Electric Co. · Sep 1987
CT9800 QUICK 3D #B7919DA
K871859 · General Electric Co. · Aug 1987
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · Toshiba Medical Systems · Dec 1986