Cleared Traditional

K880981 - A2J MZ 44 B TYPE (FDA 510(k) Clearance)

Class I Radiology device.

K880981 · A2j, Inc. · Radiology device
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Apr 1988
Decision
45d
Days
Class 1
Risk

K880981 is an FDA 510(k) clearance for the A2J MZ 44 B TYPE. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by A2j, Inc. (Houston, US). The FDA issued a Cleared decision on April 22, 1988 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - 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 A2j, Inc. devices

Submission Details

510(k) Number K880981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date April 22, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
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.