Cleared Traditional

K930960 - ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY

K930960 is the FDA 510(k) clearance for ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K930960 · Toshiba America Mri, Inc. · Radiology device
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Nov 1993
Decision
250d
Days
Class 2
Risk

K930960 is an FDA 510(k) clearance for the ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Mri, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 250 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 Toshiba America Mri, Inc. devices

Submission Details

510(k) Number K930960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date November 01, 1993
Days to Decision 250 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
143d slower than avg
Panel avg: 107d · This submission: 250d
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 K930960.
0.5T ASSET SYSTEM
K933835 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
K933645 · Hitachi Medical Systems America, Inc. · Nov 1993
PHILIPS GYROSCAN ACS-II RELEASE 3
K930709 · Philips Medical Systems, Inc. · Nov 1993
PHILIPS MRI BREAST COIL
K926275 · Philips Medical Systems, Inc. · Oct 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · Siemens Medical Solutions USA, Inc. · Oct 1993
MRT-50A, MRT-150A
K926001 · Toshiba America Mri, Inc. · Oct 1993