Cleared Traditional

K911642 - MRP-5000 AND MRP-7000 MULTIPLANAR RECON...

K911642 is the FDA 510(k) clearance for MRP-5000 AND MRP-7000 MULTIPLANAR RECON... 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 49-day FDA review.

K911642 · Hitachi Medical Systems America, Inc. · Radiology device
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May 1991
Decision
49d
Days
Class 2
Risk

K911642 is an FDA 510(k) clearance for the MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION. 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 May 30, 1991 after a review of 49 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 Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K911642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date May 30, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
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 K911642.
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K911806 · General Electric Co. · Jun 1991
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
K911495 · Toshiba America Mri, Inc. · Jun 1991
VISTA HPQ SYSTEM
K910715 · Philips Medical Systems (Cleveland), Inc. · Jun 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
K911667 · Hitachi Medical Systems America, Inc. · May 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
K910817 · General Electric Co. · Apr 1991
SMT-50X
K905634 · Shimadzu Medical Systems · Apr 1991