Cleared Special

K121911 - OCTAVE SPEEDER SPINE

K121911 is an FDA 510(k) clearance for OCTAVE SPEEDER SPINE, manufactured by Toshiba Medical Systems Corporation, Japan. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 49-day FDA review.

K121911 · Toshiba Medical Systems Corporation, Japan · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
49d
Days
Class 2
Risk

K121911 is an FDA 510(k) clearance for the OCTAVE SPEEDER SPINE. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Toshiba Medical Systems Corporation, Japan (Tustin, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 49 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Toshiba Medical Systems Corporation, Japan devices

FDA 510(k) Submission Details - K121911

510(k) Number K121911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2012
Decision Date August 17, 2012
Days to Decision 49 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 Peers - MOS Coil, Magnetic Resonance, Specialty

All 410
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K121911.
GE 8CH FOOT ANKLE COIL
K122694 · Ge Hangwei Medical Systems Co., Ltd. · Oct 2012
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
K122638 · Quality Electrodynamics · Sep 2012
OCTAVE SPEEDER HEAD
K121910 · Toshiba Medical Systems Corporation, Japan · Aug 2012
1.5T 16CH FLEX SPEEDER LARGE
K121362 · Neocoil, LLC · Jun 2012
MULTIARRAY KIT
K121249 · Paramed S.R.L. · Jun 2012
INFANT ARRAY
K113365 · Advanced Imaging Research Dba Sree Medical Systems · Mar 2012