Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010609444

FEI Number

3010609444

Entity Name

SMK IMAGING LLC

City/State/Country

Elmsford, NY, US

Establishment Address

8 Westchester Plz Ste 112, Elmsford, NY 10523, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SMK Imaging LLC (Owner Number: 10045679)

Owner / Operator Contact Address

8 Westchester Plaza, Suite 112, Elmsford, NY 10523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123419

PMA Number

N/A

All Registered Proprietary Names

EVA Select Digital Dental Imaging System EVA Select Size #1 EVA Select Size #2 EVA Select EVA SELECT DIRECT SIZE #1 EVA SELECT DIRECT SIZE #2 EVA SELECT DIRECT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2013-12-16

Official Correspondent

James Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SMK Imaging LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15

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2032641	CYBER MEDICAL IMAGING, INC.	Los Angeles, CA, US
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010609444. Last updated year: 2026. Please use registration number 3010609444 when referencing this establishment in official correspondence.