Cleared Traditional

K953262 - QD BILATERAL BREAST COIL

K953262 is the FDA 510(k) clearance for QD BILATERAL BREAST COIL by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K953262 · Hitachi Medical Systems America, Inc. · Radiology device
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Oct 1995
Decision
96d
Days
Class 2
Risk

K953262 is an FDA 510(k) clearance for the QD BILATERAL BREAST COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on October 17, 1995 after a review of 96 days - within the typical 510(k) review window.

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 Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K953262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date October 17, 1995
Days to Decision 96 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
11d faster than avg
Panel avg: 107d · This submission: 96d
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 K953262.
CLINICAL PROTON SPECTROSCOPY OPTION
K951650 · Siemens Medical Solutions USA, Inc. · Nov 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
K954355 · General Electric Co. · Nov 1995
IRIS BILATERAL TMJ
K953248 · Hitachi Medical Systems America, Inc. · Oct 1995
MAGNETOM VISION (PROJECT 016)
K945517 · Siemens Medical Solutions USA, Inc. · Oct 1995
GYRES 2T PRESTIGE
K945791 · Elscint, Inc. · Sep 1995
OUTLOOK
K945827 · Philips Medical Systems (Cleveland), Inc. · Sep 1995