Data / Medical devices / United States / Riverain Technologies

Riverain Technologies: FDA-registered device maker in Miamisburg, OH, United States, 7 510(k) clearances and 1 PMA approval

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

Riverain Technologies is registered with the FDA (registration 3005156333) in Miamisburg, OH, United States. It lists 5 device types. The FDA files 7 510(k) clearances and 1 PMA approval under its listings, the newest dated December 3, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005156333
Address: 3130 South Tech BLVD., Miamisburg, OH, United States, 45342
Owner or operator: Riverain Technologies (9066125)
Roles: Manufacturer
First device listed: May 10, 2005
Registered through: 2026
Brand names listed: ClearRead +Compare, ClearRead +Confirm, ClearRead +Detect, ClearRead Bone Suppress, ClearRead Bone Suppression, ClearRead CT, ClearRead CT CAC, ClearRead Enhanced and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Medical Image	MYN	2	Manufacturer	accessdata.fda.gov
Lung Computed Tomography System, Computer-Aided Detection	OEB	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Prioritization Software For Lesions	QFM	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	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
December 3, 2024	K242188	ClearRead CT CAC	JAK	Substantially Equivalent	Riverain Technologies, Inc.	accessdata.fda.gov
December 5, 2022	K221612	ClearRead CT	OEB	Substantially Equivalent	Riverain Technologies, Inc.	accessdata.fda.gov
March 10, 2022	K213566	ClearRead Xray Pneumothorax	QFM	Substantially Equivalent	Riverain Technologies, Inc.	accessdata.fda.gov
September 9, 2016	K161201	ClearRead CT	OEB	Substantially Equivalent	Riverain Technologies, LLC	accessdata.fda.gov
December 27, 2012	K123526	CLEARREAD +CONFIRM	LLZ	Substantially Equivalent	Riverain Technologies	accessdata.fda.gov
December 28, 2011	K111776	DELTAVIEW MODEL 2.1	LLZ	Substantially Equivalent	Riverain Medical Group,Llc	accessdata.fda.gov
March 18, 2010	K092363	SOFTVIEW, MODEL 2.01	LLZ	Substantially Equivalent	Riverain Medical Group	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 12, 2001	P000041	RAPIDSCREEN RS-2000	MYN	8	February 27, 2012	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 4, 2006	35456	Not yet classified	Terminated	RapidScreen RS-2000D, Medical Image Analyzer.	The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.	accessdata.fda.gov

Compare with other makers

Updated December 3, 2024. 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.