Cleared Traditional

K882453 - POLYSCAN DIGITAL SCANNER

K882453 is an FDA 510(k) clearance for POLYSCAN DIGITAL SCANNER, manufactured by Medical and Scientific Enterprises, Inc.. The device is a Class 1 Radiology device with product code IYW cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K882453 · Medical and Scientific Enterprises, Inc. · Radiology device
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Nov 1988
Decision
162d
Days
Class 1
Risk

K882453 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 Medical and Scientific Enterprises, Inc. (Sudbury, US). The FDA issued a Cleared decision on November 23, 1988 after a review of 162 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 Medical and Scientific Enterprises, Inc. devices

FDA 510(k) Submission Details - K882453

510(k) Number K882453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date November 23, 1988
Days to Decision 162 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 107d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

IYW Device Classification - Class 1, General Controls

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.