Data / Medical devices / Italy / VISIA imaging S.r.l.
VISIA imaging S.r.l.: FDA-registered device maker in San Giovanni Valdarno Arezzo, Italy, 4 510(k) clearances
VISIA imaging S.r.l. is registered with the FDA (registration 3007913988) in San Giovanni Valdarno Arezzo, Italy. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007913988
- Address
- Via Martiri della Liberta, 95/e, San Giovanni Valdarno Arezzo, Italy, 52027
- Owner or operator
- VISIA imaging S.r.l. (10030371)
- Roles
- Manufacturer
- First device listed
- September 24, 2009
- Registered through
- 2026
- Brand names listed
- ALADDIN HW3, ALADDIN TMS, ALADDIN-M, CA-200, CA-200F, CA-800, CC-100 HW6, CC-100XP HW6 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Manufacturer | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Manufacturer | accessdata.fda.gov |
| Device, Analysis, Anterior Segment | MXK | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Manufacturer | accessdata.fda.gov |
| Keratoscope, Ac-Powered | HLQ | 1 | Manufacturer | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Manufacturer | accessdata.fda.gov |
| Refractometer, Ophthalmic | HKO | 1 | Manufacturer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | 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 29, 2023 | K222933 | MYAH | MXK | Substantially Equivalent | Visia Imaging S.R.L. | accessdata.fda.gov |
| March 1, 2022 | K211868 | MYAH | MXK | Substantially Equivalent | Visia Imaging S.R.L. | accessdata.fda.gov |
| October 5, 2016 | K160327 | ALADDIN HW3.0 | HJO | Substantially Equivalent | Visia Imaging S.R.L. | accessdata.fda.gov |
| June 5, 2014 | K131567 | ALADDIN | HJO | Substantially Equivalent | Visia Imaging S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Biomicroscope, Slit-Lamp, Ac-Powered
- All makers of Perimeter, Automatic, Ac-Powered
- All makers of Device, Analysis, Anterior Segment
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Refractometer, Ophthalmic
- All makers of Instrument, Measuring, Lens, Ac-Powered
Updated June 29, 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.