Cleared Traditional

K844578 - NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA

K844578 is an FDA 510(k) clearance for NON-MAGNETIC EXAMINATION TABLE FOR MAGN..., manufactured by Engineering Dynamics Corp.. The device is a Class 2 Radiology device with product code FPO cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K844578 · Engineering Dynamics Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
172d
Days
Class 2
Risk

K844578 is an FDA 510(k) clearance for the NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Engineering Dynamics Corp. (Lowell, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 172 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.6910 - 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 Engineering Dynamics Corp. devices

FDA 510(k) Submission Details - K844578

510(k) Number K844578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date May 14, 1985
Days to Decision 172 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 107d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPO Device Classification - Class 2, Special Controls

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
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 - FPO Stretcher, Wheeled

All 17
Devices cleared under the same product code (FPO) and FDA review panel - the closest regulatory comparables to K844578.
MODEL #527 OPHTHALMIC STRETCHER
K904011 · Midmark Corp. · Oct 1990
KEYMED OFFICE COUCH
K854304 · Keymed, Inc. · Nov 1985
THE KEYMED VARI-HEIGHT PATIENT COUCH
K853421 · Keymed, Inc. · Sep 1985
CENTURIAN HYDRAULIC STRETCHER
K843439 · American Sterilizer Co. · Sep 1984
KEYMED MOBILE ENDOSCOPY PATIENT COUCH
K840920 · Keymed, Inc. · Mar 1984