Data / Medical devices / United States / SMK Imaging LLC
SMK Imaging LLC: FDA-registered device maker in Elmsford, NY, United States, 1 510(k) clearance
SMK Imaging LLC is registered with the FDA (registration 3010609444) in Elmsford, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 27, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010609444
- Address
- 8 Westchester Plz Ste 112, Elmsford, NY, United States, 10523
- Owner or operator
- SMK Imaging LLC (10045679)
- Roles
- Manufacturer
- First device listed
- December 16, 2013
- Registered through
- 2026
- Brand names listed
- EVA SELECT DIRECT, EVA SELECT DIRECT SIZE #1, EVA SELECT DIRECT SIZE #2, EVA Select, EVA Select Digital Dental Imaging System, EVA Select Size #1, EVA Select Size #2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | 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 |
|---|---|---|---|---|---|---|
| December 27, 2012 | K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM | MUH | Substantially Equivalent | Afp Imaging Corp. | accessdata.fda.gov |
Compare with other makers
Updated December 27, 2012. 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.