Cleared Traditional

K011683 - NURVO 9000 ENDOCAVITARY COILS

K011683 is an FDA 510(k) clearance for NURVO 9000 ENDOCAVITARY COILS, manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K011683 · Usa Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
194d
Days
Class 2
Risk

K011683 is an FDA 510(k) clearance for the NURVO 9000 ENDOCAVITARY COILS. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Usa Instruments, Inc. (Aurora, US). The FDA issued a Cleared decision on December 10, 2001 after a review of 194 days - an extended review 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: 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 Usa Instruments, Inc. devices

FDA 510(k) Submission Details - K011683

510(k) Number K011683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date December 10, 2001
Days to Decision 194 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
87d slower than avg
Panel avg: 107d · This submission: 194d
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 453
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K011683.
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514 · Mri Devices Corp. · Jan 2002
SHOULDER COIL
K013541 · Usa Instruments, Inc. · Dec 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · Usa Instruments, Inc. · Dec 2001
CARDIOVASCULAR ARRAY
K013810 · W.L. Gore & Associates, Inc. · Nov 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · Mri Devices Corp. · Nov 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · Mri Devices Corp. · Nov 2001