Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225677

FEI Number

3001451453

Entity Name

UMI INTL.

City/State/Country

Norwood, NJ, US

Establishment Address

95 Hudson Ave. #3F10, Norwood, NJ 07648, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

UMI INTL. (Owner Number: 9030079)

Owner / Operator Contact Address

95 Hudson Ave. #3F10, Norwood, NJ 07648, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070634

PMA Number

N/A

All Registered Proprietary Names

Tube Stand C-Arm : Anyview-500DR X-ray Grid HFG( SXG-Series ) Bucky Stand Patient Table Portable Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2023-12-26
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2023-12-26
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2023-12-26
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-12-26
IXJ	Grid, Radiographic	Radiology	Class 1	892.1910	1997-04-17
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2023-12-26
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2023-12-26
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2023-12-26
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2007-10-10

Official Correspondent

KWANG CHAE JUNG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UMI INTL.

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
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K060344	Breakaway Imaging, LLC	O-ARM IMAGING SYSTEM	2006-03-29
K982706	Philips Medical Systems, Inc.	PHILIPS BV300 SERIES RELEASE 2.1	1998-09-02
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225677. Last updated year: 2026. Please use registration number 1225677 when referencing this establishment in official correspondence.