# K141329: Radspa

- Pathway: 510(k) (Abbreviated)
- Applicant: Telerad Tech Private Limited
- Decided: Jun 20, 2014 after 30 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: 11 generations back to K913770 (1991). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082693: Resolutionmd, Release 2.1, Calgary Scientific, Inc. (2009) Summary page 1.
- K061421: Erad Pacs, Erad, Inc. (2006) Summary page 1.

## Indications for use
RADSpa™ components are intended to be used in hospitals, imaging centers, radiologist reading practices and by any user who requires and is granted access to view patient's images, demographic and report information. RADSpa™ PACS and Viewer RADSpa™ PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices. RADSpa™ MPR/MIP/3D RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points. RADSpa™ MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization. RADSpa™ MPR/MIP/3D is not intended for mobile devices.

Source page: https://510kreport.com/device/K141329
Methodology: https://510kreport.com/methodology