# K053301: Cedara I-Response Cedara Pet/CT

- Pathway: 510(k) (Traditional)
- Applicant: Cedara Software Corp.
- Decided: Feb 3, 2006 after 67 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 15 ancestors in all.
221 later devices descend from it; 3 cite it directly.
1 of 237 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040468: Cedara I-Softview and Cedara I-Readmammo, Cedara Software Corp. (2004) Summary page 1.
- K041484: Undecided, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K123920: Syngo.Via (2013), 63 descendants of its own

## 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. Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and itcractivc manip,1lptio1n of multi-modality softeopy images. Two and three-dimensional image corcgistration (fusion) and segmentation of mulliple imaging modality data including but not limited to functional MRI, PET, SPFCT, ;d CT for user-selected regions of interest taken at different time points or generated using different scanning protocols. Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (e.g., tumors, abscesses, AVMs), or other anatomical structures. The software can help track changes in morphology, functional activity, or other responses that may occur as a result of treatment therapy or disease progression

Source page: https://510kreport.com/device/K053301
Methodology: https://510kreport.com/methodology