Cleared Traditional

K001209 - INSIGHT PLUS 9000 PHASED ARRAY TORSO AN...

K001209 is the FDA 510(k) clearance for INSIGHT PLUS 9000 PHASED ARRAY TORSO AN... by Usa Instruments, Inc.. It is a Class 2 Radiology device (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

Submission Details

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.

Device Classification

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 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