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FDA 510(k)

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

K-Number: K033712 · 2003-12-23

ApplicantSectra-Imtec AB
Decision Date2003-12-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 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 2003-12-23 under 510(k) number K033712. 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 MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1?

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 is a medical device that received FDA 510(k) clearance on 2003-12-23. The listed applicant is Sectra-Imtec AB. The 510(k) number is K033712.

When did MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 receive FDA 510(k) clearance?

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 received FDA 510(k) clearance on 2003-12-23, under 510(k) number K033712.

Who is the listed applicant for MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1?

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 MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1?

The FDA product code for MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 is LLZ.

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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: 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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