Cleared Abbreviated

K021751 - ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM

K021751 is the FDA 510(k) clearance for ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K021751 · Hitachi Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
79d
Days
Class 2
Risk

K021751 is an FDA 510(k) clearance for the ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on August 15, 2002 after a review of 79 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K021751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date August 15, 2002
Days to Decision 79 days
Submission Type Abbreviated
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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

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 299
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K021751.
HRW-63-INT WRIST ARRAY COIL
K022588 · Mri Devices Corp. · Sep 2002
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487 · Mri Devices Corp. · Aug 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488 · Mri Devices Corp. · Aug 2002
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K021631 · Mri Devices Corp. · Aug 2002
HRH-127-8 HEAD ARRAY COIL
K022372 · Mri Devices Corp. · Aug 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · Usa Instruments, Inc. · Jul 2002