Cleared Traditional

K010802 - CARDIAC VIEW, MODEL 2001

K010802 is an FDA 510(k) clearance for CARDIAC VIEW, manufactured by Magna-Lab, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K010802 · Magna-Lab, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
84d
Days
Class 2
Risk

K010802 is an FDA 510(k) clearance for the CARDIAC VIEW, MODEL 2001. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Magna-Lab, Inc. (Newton, US). The FDA issued a Cleared decision on June 8, 2001 after a review of 84 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 Magna-Lab, Inc. devices

FDA 510(k) Submission Details - K010802

510(k) Number K010802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date June 08, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
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 386
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K010802.
E-SCAN MRI SYSTEM
K012728 · Biosound Esaote, Inc. · Aug 2001
MODEL 235GE-64
K011608 · Medical Advances, Inc. · Aug 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · Mri Devices Corp. · Aug 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · Usa Instruments, Inc. · May 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505 · Mri Devices Corp. · May 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · Usa Instruments, Inc. · May 2001