Cleared Traditional

K884603 - SHOULDER TRANSMIT AND RECEIVE COILS

K884603 is an FDA 510(k) clearance for SHOULDER TRANSMIT AND RECEIVE COILS, manufactured by Diasonics, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K884603 · Diasonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
27d
Days
Class 2
Risk

K884603 is an FDA 510(k) clearance for the SHOULDER TRANSMIT AND RECEIVE COILS. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Diasonics, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diasonics, Inc. devices

FDA 510(k) Submission Details - K884603

510(k) Number K884603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date November 30, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K884603.
MT/S (SPINE TRANSMIT COIL)
K884606 · Diasonics, Inc. · Dec 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743 · Diasonics, Inc. · Dec 1988
GE MR MAX SYSTEM
K883547 · General Electric Co. · Nov 1988
MT/S CARLSON SPINE COIL, PART # 100-50082500-01
K884604 · Diasonics, Inc. · Nov 1988
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
K884369 · General Electric Co. · Nov 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062 · Siemens Medical Solutions USA, Inc. · Nov 1988