Cleared Traditional

K850761 - MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (FDA 510(k) Clearance)

Class I Radiology device.

K850761 · Medicor USA , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
206d
Days
Class 1
Risk

K850761 is an FDA 510(k) clearance for the MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C. Classified as Cart, Emergency, Cardiopulmonary (excluding Equipment) (product code BZN), Class I - General Controls.

Submitted by Medicor USA , Ltd. (Columbus, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 206 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 868.6175 - 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 Medicor USA , Ltd. devices

Submission Details

510(k) Number K850761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date September 19, 1985
Days to Decision 206 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZN Cart, Emergency, Cardiopulmonary (excluding Equipment)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6175
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.