Data / Medical devices / United States / RadmediX, LLC

RadmediX, LLC: FDA-registered device maker in Dayton, OH, United States, 8 510(k) clearances

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

RadmediX, LLC is registered with the FDA (registration 3009134655) in Dayton, OH, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 25, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009134655
Address: 2510 Lance Dr., Dayton, OH, United States, 45409
Owner or operator: RadmediX, LLC (10036858)
Roles: Manufacturer, Repackager or relabeler
First device listed: June 26, 2012
Registered through: 2026
Brand names listed: AccuPACS Local, AccuVue, AcuityCDR, AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4, AcuityDRe 1417w, AcuityDRe 1717t and more

Devices it lists

Device	Product code	Class	Role	Source
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	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
October 25, 2023	K231995	AcuityUDR	KPR	Substantially Equivalent	Radmedix, LLC	accessdata.fda.gov
July 12, 2023	K231709	AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4	MQB	Substantially Equivalent	Radmedix, LLC	accessdata.fda.gov
January 17, 2023	K223010	Portable X-ray System	EHD	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
April 30, 2021	K210919	AcuityDRe	MQB	Substantially Equivalent	Radmedix, LLC	accessdata.fda.gov
April 13, 2020	K200726	AcuityPDR	IZL	Substantially Equivalent	Radmedix, LLC	accessdata.fda.gov
January 2, 2020	K193360	Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard	KPR	Substantially Equivalent	Radmedix, LLC	accessdata.fda.gov
November 23, 2010	K102849	ACCULMAING	LLZ	Substantially Equivalent	Radiology Information Systems, Inc.	accessdata.fda.gov
December 11, 2009	K091364	DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4	LLZ	Substantially Equivalent	Oehm Und Rehbein GmbH	accessdata.fda.gov

Compare with other makers

Updated October 25, 2023. 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.