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FDA 510(k)

IDS5 IMAGE DISPLAY SYSTEM

K-Number: K001140 · 2000-05-03

ApplicantSectra AB
Decision Date2000-05-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IDS5 IMAGE DISPLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2000-05-03 under 510(k) number K001140. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS5 IMAGE DISPLAY SYSTEM?

IDS5 IMAGE DISPLAY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-03. The listed applicant is Sectra AB. The 510(k) number is K001140.

When did IDS5 IMAGE DISPLAY SYSTEM receive FDA 510(k) clearance?

IDS5 IMAGE DISPLAY SYSTEM received FDA 510(k) clearance on 2000-05-03, under 510(k) number K001140.

Who is the listed applicant for IDS5 IMAGE DISPLAY SYSTEM?

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

What is the FDA product code for IDS5 IMAGE DISPLAY SYSTEM?

The FDA product code for IDS5 IMAGE DISPLAY SYSTEM is LLZ.

Related Clinical Trials

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.

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Other records listing Sectra 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.

K232208Sectra Digital Pathology Module (Version 3.3)K193054Sectra Digital Pathology ModuleK034059SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGEK033088SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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