Cleared Abbreviated

K123508 - TRINIAS

K123508 is an FDA 510(k) clearance for TRINIAS, manufactured by Shimadzu Corporation. The device is a Class 2 Radiology device with product code OWB cleared through the Abbreviated 510(k) pathway after a 470-day FDA review.

K123508 · Shimadzu Corporation · Radiology device
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Feb 2014
Decision
470d
Days
Class 2
Risk

K123508 is an FDA 510(k) clearance for the TRINIAS. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Shimadzu Corporation (Kyoto, JP). The FDA issued a Cleared decision on February 26, 2014 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Shimadzu Corporation devices

FDA 510(k) Submission Details - K123508

510(k) Number K123508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date February 26, 2014
Days to Decision 470 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
363d slower than avg
Panel avg: 107d · This submission: 470d
Pathway characteristics
Standards-based clearance path.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 Consultant

Shimadzu Medical Systems
Jeffrey Seiler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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