# De Gotzen S.R.L.

- Location (FDA's records): Olgiate Olona, IT
- FDA decisions: 7 (2014–2023): 7 510(k) clearances
- Names in FDA's records: De Gotzen S.R.L. (5); De Götzen S.R.L. (2)
- Product codes: MUH (2), EHD (2), OAS (2), LLZ (1)
- 510(k) review time since 2016: median 213 days, against 114 for FDA's reviews in the same codes and years (0 of 6 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 3 (1 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
- Villa Sistemi Medicali S.P.A.: 3 (https://510kreport.com/company/villa-sistemi-medicali)
- Hdx Will Corp.: 1 (https://510kreport.com/company/hdx-will)
- Palodex Group OY: 1 (https://510kreport.com/company/palodex-group)
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)
- Cefla S.C.: 1 (https://510kreport.com/company/cefla-sc)

## Firms that cite its devices most
- Trident S.R.L: 1 (https://510kreport.com/company/trident)
- Midmark Corp.: 1 (https://510kreport.com/company/midmark)

## Its most-cited devices
- K160166: X-MIND trium (2016), cited by 3

## Recent decisions
- K231055: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) (Dec 28, 2023)
- K203374: X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) (Feb 5, 2021)
- K201382: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (Nov 18, 2020)
- K191719: X-MIND Trium (Feb 20, 2020)
- K192165: Acteon Imaging Suite (Feb 11, 2020)
- K160166: X-MIND trium (Nov 15, 2016)
- K132378: X-Mind Unity (May 30, 2014)

Source page: https://510kreport.com/company/de-gotzen