Cleared Traditional

K882453 - POLYSCAN DIGITAL SCANNER (FDA 510(k) Clearance)

Class I Radiology device.

K882453 · Medical and Scientific Enterprises, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.