Cleared Traditional

K922814 - TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT (FDA 510(k) Clearance)

Class I Radiology device.

K922814 · Bay Shore Medical Equipment Corp. · Radiology device
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Sep 1992
Decision
101d
Days
Class 1
Risk

K922814 is an FDA 510(k) clearance for the TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Bay Shore Medical Equipment Corp. (Bay Shore, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Bay Shore Medical Equipment Corp. devices

Submission Details

510(k) Number K922814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date September 11, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
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.