Cleared Traditional

K901952 - MAG RESON DIAG DEV ACCESS SPEC PURP REC...

K901952 is the FDA 510(k) clearance for MAG RESON DIAG DEV ACCESS SPEC PURP REC... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K901952 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
108d
Days
Class 2
Risk

K901952 is an FDA 510(k) clearance for the MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on August 17, 1990 after a review of 108 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K901952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date August 17, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
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 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K901952.
GYREX 2T VERSION 2.1U.
K903028 · Elscint, Inc. · Sep 1990
VISTA MR 2055 HP SYSTEM
K903048 · Philips Medical Systems (Cleveland), Inc. · Aug 1990
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933 · General Electric Co. · Aug 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K903319 · GE Medical Systems · Aug 1990
PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
K901888 · Medrad, Inc. · Aug 1990
LARGE FLEXIBLE BODY COIL
K902314 · Toshiba America Mri, Inc. · Aug 1990