Cleared Traditional

K881386 - X-RAY GENERATING SYSTEM TF 1000 (FDA 510(k) Clearance)

Class I Radiology device.

K881386 · General Medical Merate S.P.A · Radiology device
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Jul 1988
Decision
98d
Days
Class 1
Risk

K881386 is an FDA 510(k) clearance for the X-RAY GENERATING SYSTEM TF 1000. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by General Medical Merate S.P.A (Long Island City, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 98 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 General Medical Merate S.P.A devices

Submission Details

510(k) Number K881386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date July 08, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
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.