Cleared Traditional

K964626 - EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE

K964626 is the FDA 510(k) clearance for EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE 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 83-day FDA review.

K964626 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
83d
Days
Class 2
Risk

K964626 is an FDA 510(k) clearance for the EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE. 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 February 10, 1997 after a review of 83 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 K964626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1996
Decision Date February 10, 1997
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
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 K964626.
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990 · Philips Medical Systems, Inc. · May 1997
ARTOSCAN M
K963262 · Biosound, Inc. · Mar 1997
KINEMATIC POSITIONING DEVICES
K964752 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
MRT-35A V9.0
K964608 · Toshiba America Mri, Inc. · Feb 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · General Electric Co. · Jan 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370 · GE Medical Systems · Jan 1997