Data / Medical devices / United States / Notalvision Inc.
Notalvision Inc.: FDA-registered device maker in Manassas, VA, United States, 2 510(k) clearances
Notalvision Inc. is registered with the FDA (registration 3008364787) in Manassas, VA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008364787
- Address
- 7717 Coppermine Dr, Manassas, VA, United States, 20109
- Owner or operator
- NOTALVISION INC. (9058077)
- Roles
- Repackager or relabeler
- First device listed
- January 9, 2010
- Registered through
- 2027
- Brand names listed
- ForeseeHome, SCANLY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device | SAX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 15, 2024 | DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | SAX | Unknown | Notal Vision, Inc. | accessdata.fda.gov |
| December 23, 2009 | K091579 | FORESEE HOME | HPT | Substantially Equivalent | Notal Vision , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 15, 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.