# K111694: ASTRA

- Pathway: 510(k) (Traditional)
- Applicant: Candelis, Inc.
- Decided: Sep 15, 2011 after 91 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: 9 generations back to K954874 (1996). 35 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092949: Imagegrid Radiology Viewer System, Candelis, Inc. (2009) Summary page 1.
- K103785: Mobile Mim, Mim Software, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K233634: TeleScan (2023), 0 descendants of its own
- K143176: UltraLinq (2015), 0 descendants of its own

## Indications for use
ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data from imaging modalities (e.g., CR and DR). Images and data can be stored, communicated, and displayed within the system or across computer systems. ASTRA is comprised with three configurations depending upon the requirements of the user and desired options: ASTRA Plus, ASTRA Lite, and ASTRA Mobile. ASTRA runs on a PC workstation, iPad, or Phone and may be interfaced with verified and validated image acquisition devices from Candelis or other PACS systems. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. ASTRA Plus is used to: share reports and studies with other ASTRA peers review reports and studies download and save reports send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) route studies to PACS, Workstations, or other ASTRA peers ASTRA Lite is used to: share reports and studies with other ASTRA peers review reports and studies download and save reports send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) ASTRA Mobile is used to: share reports with other ASTRA peers review reports download and save reports send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) 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 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K111694
Methodology: https://510kreport.com/methodology