Cleared Traditional

IMAGEACCESS SYSTEM (K931454) - FDA 510(k) Clearance

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

K931454 · Image Premastering Services, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
266d
Days
Class 2
Risk

K931454 is an FDA 510(k) clearance for the IMAGEACCESS SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Image Premastering Services, Inc. (Washington, US). The FDA issued a Cleared decision on December 14, 1993 after a review of 266 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 Image Premastering Services, Inc. devices

Submission Details

510(k) Number K931454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1993
Decision Date December 14, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
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 K931454.
SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM
K931298 · General Electric Co. · Jan 1994
MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016
K932271 · Siemens Medical Solutions USA, Inc. · Jan 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K934499 · GE Medical Systems · Dec 1993
MERIT
K933356 · Philips Medical Systems (Cleveland), Inc. · Dec 1993
1.5T EDGE AND 1.0T VISTA SYSTEMS
K931544 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
0.5T ASSET SYSTEM
K933835 · Philips Medical Systems (Cleveland), Inc. · Nov 1993