# K213660: RadAlly

- Pathway: 510(k) (Abbreviated)
- Applicant: Imaging Wave, LLC
- Decided: Mar 31, 2023 after 494 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: 6 generations back to K010259 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110332: Clearcanvas Ris / Pacs, Clearcanvas, Inc. (2011) Summary page 4.

## Indications for use
RadAlly™ is a software Medical Image Management and Processing System (MIMPS) intended to transfer, display, archive, and review medical images in DICOM format for diagnostic use by a licensed practitioner, such as a radiologist or any physician maintaining the correct licensing criteria to read and interpret medical images. RadAlly™ supports multimodality imaging such as Ultrasound (US), Digitized X-Ray Film (SC), Digital Radiography (DR), Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR) Imaging. RadAlly™ is not intended for use with mammography – either film or full field digital mammography (FFDM) or tomosynthesis (Tomo or 3D Mammo). It is also not intended for use with nuclear medicine, PET, SPECT or CT fusion imaging. RadAlly™ is not indicated for use on mobile displays. RadAlly™ may be interfaced with other DICOM modalities or MIMPS systems. All pertinent patient information may be displayed simultaneously. The viewer includes standard image measurement tools such as distance. RadAlly™ also includes manual measurement tools for use with ultrasound cardiac imaging, including Pressure-Half Time (PHT), Velocity-Time Integral (VTI), Aortic Valve Area (AVA) and Mitral Valve Area (MVA).

Source page: https://510kreport.com/device/K213660
Methodology: https://510kreport.com/methodology