Registered with FDA
RadmediX, LLC
Dayton, OH, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name RadmediX, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | RadmediX, LLC | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | RADMEDIX LLC. | 3 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What RadmediX, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | AcuityDX+ | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
RadmediX, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Iray Technology Taicang , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Jan 2023 | K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RadmediX, LLCFDA reg. 3009134655 | Dayton, OH, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036858). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.