Cleared Traditional

K902217 - TEMPOROMANDIBULAR JOINT (TMJ) COIL

K902217 is an FDA 510(k) clearance for TEMPOROMANDIBULAR JOINT (TMJ) COIL, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K902217 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
128d
Days
Class 2
Risk

K902217 is an FDA 510(k) clearance for the TEMPOROMANDIBULAR JOINT (TMJ) 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 September 21, 1990 after a review of 128 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

FDA 510(k) Submission Details - K902217

510(k) Number K902217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date September 21, 1990
Days to Decision 128 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 963
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K902217.
GYROSCAN S15/ACS
K902799 · Philips Medical Systems, Inc. · Oct 1990
MODEL 4500-SMS-42
K903822 · Medical Advances, Inc. · Oct 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
K903527 · Siemens Medical Solutions USA, Inc. · Sep 1990
GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP
K902663 · General Electric Co. · Sep 1990
GYREX 2T VERSION 2.1U.
K903028 · Elscint, Inc. · Sep 1990
VISTA MR 2055 HP SYSTEM
K903048 · Philips Medical Systems (Cleveland), Inc. · Aug 1990