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FDA 510(k)

SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1

K-Number: K033088 · 2003-10-29

ApplicantSectra AB
Decision Date2003-10-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 is the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K033088. 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 SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1?

SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Sectra AB. The 510(k) number is K033088.

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

SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 received FDA 510(k) clearance on 2003-10-29, under 510(k) number K033088.

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

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 SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1?

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

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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 PACKAGEK001140IDS5 IMAGE DISPLAY SYSTEM

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.

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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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