Cleared Special

K053017 - MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS

K053017 is an FDA 510(k) clearance for MODELS HRS-63-8 AND HRS-127-8 SHOULDER ..., manufactured by Invivo Corporation. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 21-day FDA review.

K053017 · Invivo Corporation · Radiology device
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Nov 2005
Decision
21d
Days
Class 2
Risk

K053017 is an FDA 510(k) clearance for the MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corporation (Pewaukee, US). The FDA issued a Cleared decision on November 16, 2005 after a review of 21 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.

FDA 510(k) Submission Details - K053017

510(k) Number K053017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date November 16, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K053017.
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K052704 · Invivo Corp. · Nov 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827 · Medrad, Inc. · Nov 2005
K053017 · MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
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