Cleared Traditional

K900064 - VISTA HPQ SYSTEM

K900064 is the FDA 510(k) clearance for VISTA HPQ SYSTEM 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 64-day FDA review.

K900064 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Mar 1990
Decision
64d
Days
Class 2
Risk

K900064 is an FDA 510(k) clearance for the VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM. 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 March 9, 1990 after a review of 64 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 K900064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1990
Decision Date March 09, 1990
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
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 K900064.
MODEL 8010
K901092 · Medical Advances, Inc. · Apr 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K900889 · Siemens Medical Solutions USA, Inc. · Mar 1990
MRT 50A SOFTWARE RELEASE 9.0
K900283 · Toshiba America Mri, Inc. · Mar 1990
MRT 50A 150MM CIRCULAR SURFACE COIL
K900284 · Toshiba America Mri, Inc. · Mar 1990
MRT 50A FLEXIBLE BODY COIL
K900285 · Toshiba America Mri, Inc. · Mar 1990
MRT 50A BRAIN QD COIL
K900288 · Toshiba America Mri, Inc. · Mar 1990