# K092949: Imagegrid Radiology Viewer System

- Pathway: 510(k) (Traditional)
- Applicant: Candelis, Inc.
- Decided: Oct 8, 2009 after 14 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
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Imagegrid: named in the summary without a submission number
- (no number) Integradweb: named in the summary without a submission number

## Most influential descendants
- K111694: ASTRA (2011), 5 descendants of its own
- K140960: Picture Archiving and Communications System (2014), 3 descendants of its own
- K190694: Unifi Workspace v1.0.0 (2019), 2 descendants of its own
- K220767: TeleScan (2022), 1 descendant of its own
- K262143: ImageGrid StreamVue (2026), 0 descendants of its own

## Indications for use
ImageGrid Radiology Viewer SystemTM is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K092949
Methodology: https://510kreport.com/methodology