Cleared Traditional

K854976 - RMI RESPIRATORY GATING SYSTEM MODEL 301

K854976 is an FDA 510(k) clearance for RMI RESPIRATORY GATING SYSTEM MODEL 301, manufactured by Radiation Measurements, Inc.. The device is a Class 1 Radiology device with product code IXO cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K854976 · Radiation Measurements, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
146d
Days
Class 1
Risk

K854976 is an FDA 510(k) clearance for the RMI RESPIRATORY GATING SYSTEM MODEL 301. Classified as Synchronizer, Ecg / Respirator, Radiographic (product code IXO), Class I - General Controls.

Submitted by Radiation Measurements, Inc. (Middleton, US). The FDA issued a Cleared decision on May 7, 1986 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1970 - 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 Radiation Measurements, Inc. devices

FDA 510(k) Submission Details - K854976

510(k) Number K854976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date May 07, 1986
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

IXO Device Classification - Class 1, General Controls

Product Code IXO Synchronizer, Ecg / Respirator, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1970
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.