Cleared Abbreviated

K073310 - OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL (FDA 510(k) Clearance)

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

K073310 · Hitachi Medical Corp. · Radiology device
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Jan 2008
Decision
56d
Days
Class 2
Risk

K073310 is an FDA 510(k) clearance for the OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Hitachi Medical Corp. (Twinsburg, US). The FDA issued a Cleared decision on January 18, 2008 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Hitachi Medical Corp. devices

Submission Details

510(k) Number K073310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2007
Decision Date January 18, 2008
Days to Decision 56 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - MOS Coil, Magnetic Resonance, Specialty

All 487
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