Cleared Abbreviated

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE (K032443) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032443 · Shimadzu Corp. · Radiology device
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Feb 2004
Decision
196d
Days
Class 2
Risk

K032443 is an FDA 510(k) clearance for the DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 196 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shimadzu Corp. devices

Submission Details

510(k) Number K032443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2003
Decision Date February 20, 2004
Days to Decision 196 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 107d · This submission: 196d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 36
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