# K092915: Cedara Webaccess, Model: 2.4

- Pathway: 510(k) (Traditional)
- Applicant: Cedara Software Corp.
- Decided: Jun 23, 2010 after 274 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (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). 10 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022881: Cedara I-Softview, Cedara Software Corp. (2002) Summary page 1.
- K051325: Webpax, Model 200, Heart Imaging Technologies, LLC (2005) Summary page 1.

## Most influential descendants
- K111892: Vitreaview Software 6.1 (2011), 16 descendants of its own
- K122136: Vitreaview (2012), 15 descendants of its own
- K150738: VitreaView (2015), 8 descendants of its own
- K163232: Vitrea View (2017), 7 descendants of its own
- K190764: SurgicalAR (2019), 6 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.
- May 25, 2016 · Class II · Z-0611-2017: Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
- Jan 30, 2016 · Class II · Z-2531-2016: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit)
- Jan 30, 2016 · Class II · Z-2532-2016: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit)

## Indications for use
Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K092915
Methodology: https://510kreport.com/methodology