Data / Medical devices / Italy / Imaginalis S.r.l.
Imaginalis S.r.l.: FDA-registered device maker in Sesto Fiorentino Firenze, Italy, 2 510(k) clearances
Imaginalis S.r.l. is registered with the FDA (registration 3012957335) in Sesto Fiorentino Firenze, Italy. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012957335
- Address
- Via Rodolfo Morandi, 13-15, Sesto Fiorentino Firenze, Italy, 50019
- Owner or operator
- Epica International (10078585)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 28, 2020
- Registered through
- 2026
- Brand names listed
- SEE FACTOR CT3, SeeFactor CT3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| June 21, 2024 | K233230 | See Factor CT3 | OWB | Substantially Equivalent | Epica International, Inc. | accessdata.fda.gov |
| September 20, 2019 | K190856 | SeeFactorCT3 | OAS | Substantially Equivalent | Epica International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of Interventional Fluoroscopic X-Ray System
Updated June 21, 2024. 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.