Cleared Abbreviated

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION (K080701) - FDA 510(k) Clearance

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

K080701 · Shimadzu Corp. · Radiology device
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May 2008
Decision
64d
Days
Class 2
Risk

K080701 is an FDA 510(k) clearance for the SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 K080701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date May 14, 2008
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 93
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