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FDA 510(k)

WISE (II) IMAGE MANAGEMENT SYSTEM

K-Number: K983447 · 1998-10-29

ApplicantSectra-Imtec AB
Decision Date1998-10-29
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WISE (II) IMAGE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sectra-Imtec AB. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K983447. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WISE (II) IMAGE MANAGEMENT SYSTEM?

WISE (II) IMAGE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Sectra-Imtec AB. The 510(k) number is K983447.

When did WISE (II) IMAGE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

WISE (II) IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance on 1998-10-29, under 510(k) number K983447.

Who is the listed applicant for WISE (II) IMAGE MANAGEMENT SYSTEM?

The FDA 510(k) record lists Sectra-Imtec AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WISE (II) IMAGE MANAGEMENT SYSTEM?

The FDA product code for WISE (II) IMAGE MANAGEMENT SYSTEM is LMB.

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Other records listing Sectra-Imtec AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110025SECTRA MICRODOSE MAMMOGRAPHYK081469SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2K063093SECTRA WORKSTATION, VERSION 11.1K051315MODIFICATION TO: SECTRA IDS5 WORKSTATIONK050196SECTRA IDS5 WORKSTATIONK040376SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE

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Related Devices (Code: LMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, Inc.K972380KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)Eastman Kodak Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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