Cleared Traditional

K122897 - SENSE HEAD 16 MODEL 800647

Also marketed or referenced as:
SENSE TORSO 16 MODEL 800645

K122897 is an FDA 510(k) clearance for SENSE HEAD 16 MODEL 800647, manufactured by Invivo Corporation. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K122897 · Invivo Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
91d
Days
Class 2
Risk

K122897 is an FDA 510(k) clearance for the SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corporation (Florida, US). The FDA issued a Cleared decision on December 21, 2012 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Invivo Corporation devices

FDA 510(k) Submission Details - K122897

510(k) Number K122897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date December 21, 2012
Days to Decision 91 days
Submission Type Traditional
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
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K122897.
TRILLIUM Oval Head Coil 32
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K162177 · Invivo Corporation · Sep 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · Invivo Corporation · Aug 2016
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492 · Philips Medical Systems · Dec 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K122646 · Invivo Corporation · Nov 2012
SENSE MSK S 8CH 1.5T
K120122 · Invivo Corporation · Feb 2012