Cleared Abbreviated

K073310 - OASIS CTL COIL

K073310 is the FDA 510(k) clearance for OASIS CTL COIL by Hitachi Medical Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

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 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K073310.
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
K081745 · Hitachi Medical Systems America, Inc. · Aug 2008
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
K081198 · Hitachi Medical Systems America, Inc. · Jun 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
K080062 · Hitachi Medical Systems America, Inc. · Feb 2008
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
K072909 · Siemens AG Medical Solutions · Oct 2007
NORAS OR HEAD HOLDER
K071179 · Siemens Medical Solutions USA, Inc. · Jun 2007
ECHELON MR-RCC-150 CARDIAC COIL
K063513 · Hitachi Medical Systems America, Inc. · Dec 2006