# K012290: Rapidia

- Pathway: 510(k) (Traditional)
- Applicant: 3D Med Co., Ltd.
- Decided: Sep 28, 2001 after 70 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: 3 generations back to K954678 (1996). 3 ancestors in all.
78 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999). Our OCR of the scanned summary read K993654, FDA’s number for Neurocomp (Neurocybernetics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Plug’n View 3D”.

## Most influential descendants
- K021099: Rex, Version 1.0 (2002), 77 descendants of its own
- K030457: Rex, Version 3.0 (2003), 76 descendants of its own
- K033955: RTIST (2004), 75 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K102687: Mirada RT (2010), 37 descendants of its own

## Indications for use
Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT and MR scanners. Rapidia.® can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and issuing reports.

Source page: https://510kreport.com/device/K012290
Methodology: https://510kreport.com/methodology