Manufacturer registered with FDA
SMK Imaging LLC
Elmsford, NY, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What SMK Imaging 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 |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | EVA SelectEVA Select Digital Dental Imaging SystemEVA SELECT DIRECTEVA SELECT DIRECT SIZE #1EVA SELECT DIRECT SIZE #2EVA Select Size #1EVA Select Size #2 | 2013 |
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
SMK Imaging 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: Afp Imaging Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Dec 2012 | K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM | Afp Imaging Corp. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMK IMAGING LLCFDA reg. 3010609444 | Elmsford, NY, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045679). 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.