Cleared Traditional

K974498 - STRATIS II

K974498 is the FDA 510(k) clearance for STRATIS II by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974498 · Hitachi Medical Systems America, Inc. · Radiology device
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Feb 1998
Decision
90d
Days
Class 2
Risk

K974498 is an FDA 510(k) clearance for the STRATIS II. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on February 26, 1998 after a review of 90 days - within the typical 510(k) review window.

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 Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K974498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1997
Decision Date February 26, 1998
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K974498.
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K980114 · GE Medical Systems · Mar 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
K974844 · Philips Medical Systems (Cleveland), Inc. · Mar 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
K974614 · Elscint, Inc. · Mar 1998
AIRIS II
K974212 · Hitachi Medical Systems America, Inc. · Feb 1998
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
K974530 · Philips Medical Systems (Cleveland), Inc. · Feb 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972990 · GE Medical Systems · Feb 1998