# K032401: Orthoview

- Pathway: 510(k) (Traditional)
- Applicant: Omsbar, Ltd.
- Decided: Aug 14, 2003 after 10 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: 5 generations back to K896095 (1990). 6 ancestors in all.
133 later devices descend from it; 4 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002)

## Most influential descendants
- K042816: Traumacad 1.2 (2004), 129 descendants of its own
- K073714: Traumacad Version 2.0 (2008), 117 descendants of its own
- K111019: Surgimap (TM) Spine (2011), 51 descendants of its own
- K142923: TraumaCad Mobile Release 1.0 (2015), 28 descendants of its own
- K141669: Surgimap (2014), 27 descendants of its own

## Indications for use
OrthoviewTM is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

Source page: https://510kreport.com/device/K032401
Methodology: https://510kreport.com/methodology