Cleared Traditional

HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K890092) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K890092 · Health Images, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
164d
Days
Class 2
Risk

K890092 is an FDA 510(k) clearance for the HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Health Images, Inc. (Atlanta, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Health Images, Inc. devices

Submission Details

510(k) Number K890092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1989
Decision Date June 23, 1989
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K890092.
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 AND 2055 UPGRADES
K893739 · Philips Medical Systems (Cleveland), Inc. · Jul 1989
VISTA MR 2055 HP SYSTEM
K893619 · Philips Medical Systems (Cleveland), Inc. · Jun 1989
MAGNISCAN 5000 MR SYSTEM
K891769 · General Electric Co. · Jun 1989
GE SHOULDER SURFACE COIL, CAT. #M1085AN
K892235 · General Electric Co. · May 1989