Cleared Special

K983447 - WISE (II) IMAGE MANAGEMENT SYSTEM

K983447 is an FDA 510(k) clearance for WISE (II) IMAGE MANAGEMENT SYSTEM, manufactured by Sectra-Imtec AB. The device is a Class 1 Radiology device with product code LMB cleared through the Special 510(k) pathway after a 29-day FDA review.

K983447 · Sectra-Imtec AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
29d
Days
Class 1
Risk

K983447 is an FDA 510(k) clearance for the WISE (II) IMAGE MANAGEMENT SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Sectra-Imtec AB (Plano, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K983447

510(k) Number K983447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1998
Decision Date October 29, 1998
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
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.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 44
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K983447 · WISE (II) IMAGE MANAGEMENT SYSTEM
Download PDF FDA Summary Sectra-Imtec AB