# Disior, Ltd.

- Location (FDA's records): Helsinki Uusimaa, FI
- FDA decisions: 6 (2021–2026): 6 510(k) clearances
- Product codes: QIH (4), LLZ (1), OSN (1)
- 510(k) review time since 2016: median 106 days, against 141 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Materialise NV: 1 (https://510kreport.com/company/materialise)
- Arrowhead De, LLC: 1 (https://510kreport.com/company/arrowhead)
- Orthohub, Inc.: 1 (https://510kreport.com/company/orthohub)

## Firms that cite its devices most
- AI Planning Logic, Inc.: 1 (https://510kreport.com/company/ai-planning-logic)

## Its most-cited devices
- K223757: Bonelogic (2023), cited by 3
- K240642: SMART Bun-Yo-Matic CT (2024), cited by 2
- K203290: Bonelogic (2021), cited by 1

## Recent decisions
- K253764: ENOS Software Guided External Fixation System (Feb 26, 2026)
- K250023: Smart PCFD (Sep 29, 2025)
- K240736: SMART Bun-Yo-Matic X-Ray (Jul 2, 2024)
- K240642: SMART Bun-Yo-Matic CT (Jun 20, 2024)
- K223757: Bonelogic (Dec 8, 2023)
- K203290: Bonelogic (Feb 5, 2021)

Source page: https://510kreport.com/company/disior