Cleared Traditional

K922814 - TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT

K922814 is an FDA 510(k) clearance for TEC1410 ANATOMICAL PROGRAMMING GENERATO..., manufactured by Bay Shore Medical Equipment Corp.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K922814

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.

IZO Device Classification - Class 1, General Controls

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.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

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