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FDA 510(k)

MODIFICATION TO: SECTRA IDS5 WORKSTATION

K-Number: K051315 · 2005-06-15

ApplicantSectra Imtec AB
Decision Date2005-06-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: SECTRA IDS5 WORKSTATION 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 2005-06-15 under 510(k) number K051315. 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 WORKSTATION?

MODIFICATION TO: SECTRA IDS5 WORKSTATION is a medical device that received FDA 510(k) clearance on 2005-06-15. The listed applicant is Sectra Imtec AB. The 510(k) number is K051315.

When did MODIFICATION TO: SECTRA IDS5 WORKSTATION receive FDA 510(k) clearance?

MODIFICATION TO: SECTRA IDS5 WORKSTATION received FDA 510(k) clearance on 2005-06-15, under 510(k) number K051315.

Who is the listed applicant for MODIFICATION TO: SECTRA IDS5 WORKSTATION?

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 WORKSTATION?

The FDA product code for MODIFICATION TO: SECTRA IDS5 WORKSTATION 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 11.1K050196SECTRA IDS5 WORKSTATIONK040376SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGEK033712MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

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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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