Cleared Traditional

K905070 - VISTAR

K905070 is the FDA 510(k) clearance for VISTAR by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K905070 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jan 1991
Decision
54d
Days
Class 2
Risk

K905070 is an FDA 510(k) clearance for the VISTAR. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on January 2, 1991 after a review of 54 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K905070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1990
Decision Date January 02, 1991
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
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 K905070.
VISTA HPQ SYSTEM
K905259 · Philips Medical Systems (Cleveland), Inc. · Jan 1991
MODEL 3100-21: QUADRATURE SPINE COIL
K905095 · Medical Advances, Inc. · Jan 1991
MODEL 3100-64: QUADRATURE SPINE COIL
K905104 · Medical Advances, Inc. · Jan 1991
MRT35-SP
K905442 · Toshiba America Mri, Inc. · Dec 1990
MRT 35-A (TM)
K905441 · Toshiba America Mri, Inc. · Dec 1990
MAGNETIC RESONANCE DEVICE MRT 150A
K903768 · Toshiba America Mri, Inc. · Nov 1990