# K182464: PeekMed

- Pathway: 510(k) (Traditional)
- Applicant: Peek Health, S.A.
- Decided: Oct 25, 2018 after 45 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: 8 generations back to K896095 (1990). 21 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 5.

## Most influential descendants
- K222767: PeekMed web (v1) (2022), 8 descendants of its own
- K240926: PeekMed web (2024), 6 descendants of its own
- K250042: PeekMed web (2025), 4 descendants of its own
- K251096: PeekMed web (2025), 3 descendants of its own
- K210556: Preview Shoulder (2021), 3 descendants of its own

## Indications for use
PeekMed is a software system designed to help surgeons’ specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients’ imaging studies. The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies. PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.

Source page: https://510kreport.com/device/K182464
Methodology: https://510kreport.com/methodology