Cleared Traditional

K083014 - ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A

K083014 is an FDA 510(k) clearance for ATLAS SPEEDER HEAD/CERVICAL COIL, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K083014 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
8d
Days
Class 2
Risk

K083014 is an FDA 510(k) clearance for the ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 8 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K083014

510(k) Number K083014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date October 17, 2008
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MOS Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 490
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K083014.
16CH AI BREAST COILS 1.5 T AND 3 T
K083255 · Rapid Biomedical GmbH · Nov 2008
1.5T ATLAS SPEEDER HEAD-NECK COIL
K083160 · Quality Electrodynamics · Nov 2008
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
K082987 · Invivo · Nov 2008
HRB-127-32 HIGH RESOLUTION BRAIN COIL
K082916 · Invivo · Oct 2008
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · Quality Electrodynamics · Sep 2008
NORAS MR-BI320-PA 3T
K082373 · Noras Mri Products GmbH · Aug 2008
K083014 · ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
Download PDF FDA Summary Toshiba America Medic…