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FDA 510(k)

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE

K-Number: K040376 · 2004-05-04

ApplicantSectra-Imtec AB
Decision Date2004-05-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE 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 2004-05-04 under 510(k) number K040376. 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; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE?

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE is a medical device that received FDA 510(k) clearance on 2004-05-04. The listed applicant is Sectra-Imtec AB. The 510(k) number is K040376.

When did SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE receive FDA 510(k) clearance?

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE received FDA 510(k) clearance on 2004-05-04, under 510(k) number K040376.

Who is the listed applicant for SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE?

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 SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE?

The FDA product code for SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE 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 WORKSTATIONK033712MODIFICATION 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.

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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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