Cleared Traditional

K944684 - POLYSCAN DIGITAL SCANNER (FDA 510(k) Clearance)

Class I Radiology device.

K944684 · Mse Medizintechnik GmbH & Co. KG · Radiology device
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May 1995
Decision
235d
Days
Class 1
Risk

K944684 is an FDA 510(k) clearance for the POLYSCAN DIGITAL SCANNER. Classified as Scanner, Rectilinear, Nuclear (product code IYW), Class I - General Controls.

Submitted by Mse Medizintechnik GmbH & Co. KG (Rodemark, DE). The FDA issued a Cleared decision on May 15, 1995 after a review of 235 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1300 - 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 Mse Medizintechnik GmbH & Co. KG devices

Submission Details

510(k) Number K944684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date May 15, 1995
Days to Decision 235 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
128d slower than avg
Panel avg: 107d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYW Scanner, Rectilinear, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1300
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.