Data / Medical devices / Italy / Sit Sordina Iort Technologies SPA
Sit Sordina Iort Technologies SPA: FDA-registered device maker in aprilia Latina, Italy, 3 510(k) clearances
Sit Sordina Iort Technologies SPA is registered with the FDA (registration 3010625741) in aprilia Latina, Italy. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010625741
- Address
- via dell'industria 1/a, aprilia Latina, Italy, 04011
- Owner or operator
- SIT-Sordina IORT Technologies SpA (10043521)
- Roles
- Manufacturer
- First device listed
- February 25, 2013
- Registered through
- 2026
- Brand names listed
- ABSORBER SHIELDING, LIAC, LIAC HWL, NOVAC 11
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 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 |
|---|---|---|---|---|---|---|
| June 11, 2018 | K172961 | LIAC HWL | IYE | Substantially Equivalent | Sit Sordina Iort Technologies Spa | accessdata.fda.gov |
| April 19, 2012 | K112286 | NOVAC 11 | IYE | Substantially Equivalent | New Radiant Technology S.P.A. | accessdata.fda.gov |
| April 17, 2012 | K110840 | LIAC | IYE | Substantially Equivalent | Sordina S.P.A. | accessdata.fda.gov |
Compare with other makers
Updated June 11, 2018. 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.