Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007933232

FEI Number

3007933232

Entity Name

DIGIMED CO., LTD

City/State/Country

Seoul, KR

Establishment Address

401, 402, 406~411-ho, A-dong, 101, Gasan digital 2-ro, Geumcheon-Gu, Seoul 08505, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIGIMED (Owner Number: 10034335)

Owner / Operator Contact Address

401, 402, 406~411-ho, A-dong, 101, Gasan digital 2-ro, Geumcheon-Gu, Seoul, KR-11 08505, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082167

PMA Number

N/A

All Registered Proprietary Names

HYBRID S70 MiniX-V XTG MiniX-S DIOX-602 PROX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2023-12-27
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2019-12-30
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2010-11-24

Official Correspondent

Joonghyun Choi

US Agent Details

Shawn Kavert Business: DIGITAL DOC, LLC Email: skavert@digi-doc.com Phone: (800) 5181102

Related Public Records

Same Entity

DIGIMED

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
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3005581016	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD	GUILIN CITY Guangxi, CN
3003528079	XLINE SRL	ASSAGO Milano, IT
3002994636	DE GOTZEN S.R.L.	FAGNANO OLONA Varese, IT
3008770655	BEYES DENTAL INC	Toronto Ontario, CA
3008252267	Ningbo Runyes Medical Instrument Co., Ltd.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007933232. Last updated year: 2026. Please use registration number 3007933232 when referencing this establishment in official correspondence.