Wise (II) Image Management System

Q: What is the product code of K983447?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.

FDA 510(k) K983447 · Sectra-Imtec AB

Substantially Equivalent

510(k) numberK983447

Submission

Device name: Wise (II) Image Management System
Applicant: Sectra-Imtec AB
Plano, TX, US
Received: September 30, 1998
Decision date: October 29, 1998
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LMB – Device, Digital Image Storage, Radiological
Device class: Class I (low risk)
Regulation: 21 CFR 892.2010
Specialty: Radiology

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

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K971848	TDK Medical Grade Cd-RLMB · Traditional	Tdk Electronics Corporation of America	08/15/1997SE
K971451	Wise Image Management SystemLMB · Traditional	O Tech, Inc.	06/26/1997SE
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Questions and answers

When was Wise (II) Image Management System cleared by the FDA?

Wise (II) Image Management System (K983447) received a 510(k) decision of Substantially Equivalent on October 29, 1998, 29 days after the submission was received.

What is the product code of K983447?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.