Cleared Traditional

K853395 - RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853395 · Raytheon Medical Systems · Radiology device
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Nov 1985
Decision
81d
Days
Class 2
Risk

K853395 is an FDA 510(k) clearance for the RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Raytheon Medical Systems (Melrose Park, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 Raytheon Medical Systems devices

Submission Details

510(k) Number K853395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date November 01, 1985
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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.