# K252856: PeekMed web

- Pathway: 510(k) (Traditional)
- Applicant: Peek Health, S.A.
- Decided: Dec 22, 2025 after 104 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 13 generations back to K896095 (1990). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251096: PeekMed web, Peek Health, S.A. (2025) Summary page 6.

## Most influential descendants
- K261641: Lower Limb AI (LLAI) (2026), 0 descendants of its own

## Indications for use
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients’ imaging studies. Experience in usage and a clinical assessment are necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery, and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population.

Source page: https://510kreport.com/device/K252856
Methodology: https://510kreport.com/methodology