Cleared Traditional

K893739 - VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES

K893739 is the FDA 510(k) clearance for VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES 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 58-day FDA review.

K893739 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jul 1989
Decision
58d
Days
Class 2
Risk

K893739 is an FDA 510(k) clearance for the VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES. 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 July 14, 1989 after a review of 58 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 K893739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date July 14, 1989
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 K893739.
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
K893640 · Siemens Medical Solutions USA, Inc. · Aug 1989
VISION INTEGRATED PERFORMANCE OPTION
K893689 · Siemens Medical Solutions USA, Inc. · Jul 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893675 · Philips Medical Systems (Cleveland), Inc. · Jul 1989
VISTA MR 2055 HP SYSTEM
K893619 · Philips Medical Systems (Cleveland), Inc. · Jun 1989
ACCESS TM
K893881 · Diasonics, Inc. · Jun 1989
MAGNISCAN 5000 MR SYSTEM
K891769 · General Electric Co. · Jun 1989