Cleared Traditional

K001209 - INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL

K001209 is an FDA 510(k) clearance for INSIGHT PLUS 9000 PHASED ARRAY TORSO AN..., 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 48-day FDA review.

K001209 · Usa Instruments, Inc. · Radiology device
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Jun 2000
Decision
48d
Days
Class 2
Risk

K001209 is an FDA 510(k) clearance for the INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL. 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 June 1, 2000 after a review of 48 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.

View all Usa Instruments, Inc. devices

FDA 510(k) Submission Details - K001209

510(k) Number K001209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2000
Decision Date June 01, 2000
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
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 K001209.
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K001713 · Mri Devices Corp. · Jun 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210 · Usa Instruments, Inc. · Jun 2000
SYNERGY HEAD/NECK COIL
K001331 · Philips Medical Systems North America, Inc. · Jun 2000
LIBERTY 9000 BREAST COIL
K000993 · Usa Instruments, Inc. · May 2000
OPART, MODEL MRT-600
K000549 · Toshiba America Mri, Inc. · Apr 2000
INTERVENTIONAL BODY COIL
K000437 · Usa Instruments, Inc. · Apr 2000