# K040468: Cedara I-Softview and Cedara I-Readmammo

- Pathway: 510(k) (Special)
- Applicant: Cedara Software Corp.
- Decided: Apr 23, 2004 after 59 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904519 (1991). 6 ancestors in all.
255 later devices descend from it; 4 cite it directly.
1 of 262 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022881: Cedara I-Softview, Cedara Software Corp. (2002) Summary page 1.

## Most influential descendants
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own

## Recalls of this device
- Aug 26, 2013 · Class II · Z-0748-2014: There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted i

## Indications for use
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-modality softcopy images 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.

Source page: https://510kreport.com/device/K040468
Methodology: https://510kreport.com/methodology