# K254214: Ooopds

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- Decided: Sep 15, 2026 after 260 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 K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 5.

## Indications for use
OOOPDS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. OOOPDS is also intended for measuring and treatment planning. The OOOPDS output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replicas generated from digital output files are not for diagnostic purposes and may be used in orthopedic and maxillofacial applications. OOOPDS should be used in conjunction with expert clinical judgement.

Source page: https://510kreport.com/device/K254214
Methodology: https://510kreport.com/methodology