Data / Medical devices / Italy / De Gotzen S.R.L.
De Gotzen S.R.L.: FDA-registered device maker in FAGNANO OLONA Varese, Italy, 8 510(k) clearances
De Gotzen S.R.L. is registered with the FDA (registration 3002994636) in FAGNANO OLONA Varese, Italy. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 28, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002994636
- Address
- Strada Provinciale Busto-Cassano 3, FAGNANO OLONA Varese, Italy, 21054
- Owner or operator
- DE GOTZEN S.R.L. (9012111)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 4, 2014
- Registered through
- 2026
- Brand names listed
- AIS 3D app, Acteon Imaging Suite, RealGUIDE, U-SENSE, U-SENSE HD, X-MIND optima, X-MIND optima 3D, X-MIND prime and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 28, 2023 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | EHD | Substantially Equivalent | De Götzen S.R.L. | accessdata.fda.gov |
| February 5, 2021 | K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) | MUH | Substantially Equivalent | De Götzen S.R.L. | accessdata.fda.gov |
| November 18, 2020 | K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | OAS | Substantially Equivalent | De Gotzen S.R.L. | accessdata.fda.gov |
| February 20, 2020 | K191719 | X-MIND Trium | MUH | Substantially Equivalent | De Gotzen S.R.L. | accessdata.fda.gov |
| February 11, 2020 | K192165 | Acteon Imaging Suite | LLZ | Substantially Equivalent | De Gotzen S.R.L. | accessdata.fda.gov |
| December 20, 2018 | K173041 | 3DIEMME RealGUIDE | LLZ | Substantially Equivalent | 3Diemme , Ltd. | accessdata.fda.gov |
| May 30, 2014 | K132378 | X-MIND UNITY | EHD | Substantially Equivalent | De Gotzen S.R.L. | accessdata.fda.gov |
| April 28, 2014 | K133271 | OPTEO, VIDEOGRAPH HD | MUH | Substantially Equivalent | Owandy | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 26, 2012 | 64734 | Class II | Terminated | DeGotzen XRay unit XGenus Dental X-ray unit. | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, Image Processing, Radiological
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of System, X-Ray, Extraoral Source, Digital
Updated December 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.