# K022881: Cedara I-Softview

- Pathway: 510(k) (Traditional)
- Applicant: Cedara Software Corp.
- Decided: Oct 22, 2002 after 53 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904519 (1991). 5 ancestors in all.
413 later devices descend from it; 6 cite it directly.
1 of 419 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002936: Modification to IDS5 Image Display System, Sectra-Imtec AB (2000) Summary page 1.
- K013138: Adc Compact Plus, Agfa-Gevaert AG (2001)
- K941933: Isg Medical Imaging Family of Workstations (Mifw), I.S.G. Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- K040468: Cedara I-Softview and Cedara I-Readmammo (2004), 255 descendants of its own
- 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
- K071972: Orthopedic Software for Impax Workstations (2007), 133 descendants of its own

## Recalls of this device
- May 24, 2017 · Class II · Z-2601-2017: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
- Oct 8, 2015 · Class II · Z-0878-2017: Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
- Aug 23, 2007 · Not classified · Z-1243-2007: Defects in the Auto Launch functionality make it possible for a mismatch of patient data.

## 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. This includes the use of prosthetic template overlays 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.)

Source page: https://510kreport.com/device/K022881
Methodology: https://510kreport.com/methodology