Data / Medical devices / Italy / Xline SRL
Xline SRL: FDA-registered device maker in ASSAGO Milano, Italy, 6 510(k) clearances
Xline SRL is registered with the FDA (registration 3003528079) in ASSAGO Milano, Italy. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003528079
- Address
- Via Galilei 18, ASSAGO Milano, Italy, 20057
- Owner or operator
- XLINE S.r.l. (10061120)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 23, 2019
- Registered through
- 2026
- Brand names listed
- FONA ART Plus, FONA ART Plus C, FONA XDC, FONA XPan DG, FONA XPan DG Plus, IntraOs 70, IntraOs DG, PantOs 16 xp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 23, 2022 | K222274 | FONA XDC | EHD | Substantially Equivalent | Fona S.R.L | accessdata.fda.gov |
| March 2, 2022 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | OAS | Substantially Equivalent | Fona S.R.L | accessdata.fda.gov |
| August 30, 2021 | K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | MUH | Substantially Equivalent | Fona S.R.L | accessdata.fda.gov |
| November 3, 2016 | K161131 | FONA Pan/Ceph | MUH | Substantially Equivalent | Fona S.R.L | accessdata.fda.gov |
| September 11, 2003 | K031801 | PANTOS, MODELS: PANTOS 16, AND PANTOS DG | MUH | Substantially Equivalent | Blue X Imaging Srl | accessdata.fda.gov |
| July 8, 2003 | K031118 | INTRAOS 70 | EHD | Substantially Equivalent | Blue X Imaging Srl | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated August 23, 2022. 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.