Data / Medical devices / United States / Umi Intl.

Umi Intl.: FDA-registered device maker in Norwood, NJ, United States, 3 510(k) clearances

Name: Umi Intl. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Umi Intl. is registered with the FDA (registration 1225677) in Norwood, NJ, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 23, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1225677
FEI number: 3001451453
Address: 95 Hudson Ave. #3F10, Norwood, NJ, United States, 07648
Owner or operator: UMI INTL. (9030079)
Roles: Repackager or relabeler
First device listed: April 17, 1997
Registered through: 2026
Brand names listed: Bucky Stand, C-Arm : Anyview-500DR, C-Arm : Anyview-500R, HFG( SXG-Series ), Patient Table, Portable Unit, Tube Stand, X-ray Grid

Devices it lists

Device	Product code	Class	Role	Source
Generator, High-Voltage, X-Ray, Diagnostic	IZO	1	Repackager or relabeler	accessdata.fda.gov
Grid, Radiographic	IXJ	1	Repackager or relabeler	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Repackager or relabeler	accessdata.fda.gov
Table, Radiologic	KXJ	2	Repackager or relabeler	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Repackager or relabeler	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
March 23, 2018	K180473	ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR	OWB	Substantially Equivalent	Ecotron Co., Ltd.	accessdata.fda.gov
October 14, 2016	K160279	ANYVIEW-500R Fluoroscopic Mobile X-Ray System	OWB	Substantially Equivalent	Ecotron Co., Ltd.	accessdata.fda.gov
July 11, 2007	K070634	SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110	IZL	Substantially Equivalent	Soyee Product, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 23, 2018. 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.