Cleared Special

K983447 - WISE (II) IMAGE MANAGEMENT SYSTEM
(FDA 510(k) Clearance)

K983447 · Sectra-Imtec AB · Radiology

Oct 1998

Decision

29d

Days

Class 1

Risk

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

Submitted by Sectra-Imtec AB (Plano, US). The FDA issued a Cleared decision on October 29, 1998, 29 days after receiving the submission on September 30, 1998.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2010. Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images..

Submission Details

510(k) Number	K983447 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	LMB — Device, Digital Image Storage, Radiological
Device Class	Class I — 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.