Cleared Traditional

K875378 - SINGLE PHOTON SET 031 & AZ-701-NTS-SP E...

K875378 is an FDA 510(k) clearance for SINGLE PHOTON SET 031 & AZ-701-NTS-SP E..., manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K875378 · Shimadzu Precision Instruments, Inc. · Radiology device
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Nov 1988
Decision
321d
Days
Class 2
Risk

K875378 is an FDA 510(k) clearance for the SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on November 16, 1988 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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. Elevated predicate reliance profile. 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 - K875378

510(k) Number K875378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date November 16, 1988
Days to Decision 321 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
214d slower than avg
Panel avg: 107d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 250
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