# Orfit Industries NV

- Location (FDA's records): Wijnegem, BE
- FDA decisions: 11 (1999–2020): 11 510(k) clearances
- Names in FDA's records: Orfit Industries NV (9); Orfit Industries (2)
- Product codes: IYE (10), LHN (1)
- 510(k) review time since 2016: median 54 days, against 89 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 6 (2 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
- Bionix Development Corp.: 1 (https://510kreport.com/company/bionix-development)

## Firms that cite its devices most
- Panacea Medical Technologies Pvt., Ltd.: 2 (https://510kreport.com/company/panacea-medical-technologies-pvt)
- It-V Medizintechnik, GmbH: 1 (https://510kreport.com/company/it-v-medizintechnik)
- Diacor, Inc.: 1 (https://510kreport.com/company/diacor)

## Its most-cited devices
- K991319: Raycast Immobilization Systems Hardware and Thermoplastic Materials (1999), cited by 2
- K191158: The AIO Solution (2019), cited by 2
- K151207: Proton Immobilization Solution (2015), cited by 1
- K131795: Nanor and Efficast/Nanor Hybrid Thermoplastic Materials (2013), cited by 1

## Recent decisions
- K202068: The AIO Solution 3.0 (Aug 14, 2020)
- K200282: Orfit Aerial Couchtop (Apr 8, 2020)
- K191158: The AIO Solution (Aug 6, 2019)
- K171734: HP PRO Positioning Device (Jul 25, 2017)
- K162355: Raycast MammoRx Carbon Fibre Breast Board (Nov 22, 2016)
- K162862: Raycast High Precision Lung Board Solution (Nov 9, 2016)
- K151946: Thermofit (Nov 9, 2015)
- K151207: Proton Immobilization Solution (Jul 28, 2015)

Source page: https://510kreport.com/company/orfit-industries