CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO— 510(k) K040468

Name: FDA 510(k) clearance K040468
Creator: U.S. Food and Drug Administration
Published: 2004-04-23

Substantially Equivalent

Cedara Software Corp.

FDA 510(k) clearance K040468 for CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO, Substantially Equivalent on 2004-04-23. Applicant: Cedara Software Corp.. Device class: 2.

Clearance details

Applicant: Cedara Software Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-02-24
Decision date: 2004-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Cedara Software Corp.

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K092915 — CEDARA WEBACCESS, MODEL: 2.42010-06-23
K053301 — CEDARA I-RESPONSE CEDARA PET/CT2006-02-03
K022881 — CEDARA I-SOFTVIEW2002-10-22
K002590 — CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER2000-10-31

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K040468

K-number listed on FDA's recall record

Z-0748-2014 — Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modal softcopy image including the use of prosthetic template overlays, and including mammography. Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.) Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.Class II·Terminated·GE Healthcare It·20130826

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040468.

Data sourced from openFDA. This site is unofficial and independent of the FDA.