# K080333: Imagegrid

- Pathway: 510(k) (Traditional)
- Applicant: Candelis, Inc.
- Decided: Feb 22, 2008 after 15 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Efilm Workstation: named in the summary without a submission number
- (no number) Etiam Star Pacs Components: named in the summary without a submission number

## Most influential descendants
- K124048: Imageqube (2013), 0 descendants of its own

## Indications for use
ImageGridm is a software device and server that receives digital images and data from variuus sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). ImageGridm is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer. Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at leag 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K080333
Methodology: https://510kreport.com/methodology