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Riverain Technologies, Inc.

USA · Miamisburg

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 8 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

8 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 5 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: RIVERAIN TECHNOLOGIES · RIVERAIN TECHNOLOGIES, INC. · RIVERAIN TECHNOLOGIES, INC

FDA 510(k) clearances by year

12012 · K123526

12016 · K161201

22022 · K221612

12024 · K242188

FDA listed device types

System, Image Processing, Radiological 1Radiological Computer-Assisted Prioritization Software For Lesions 1System, X-Ray, Tomography, Computed 1Lung Computed Tomography System, Computer-Aided Detection 1Analyzer, Medical Image 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242188	ClearRead CT CAC	2024-12-03
US	K221612	ClearRead CT	2022-12-05
US	K213566	ClearRead Xray Pneumothorax	2022-03-10
BR	80117581053	ClearRead CT	Class II
CA	73298	RAPIDSCREEN RS-DIGITAL	Class II
CA	92782	CLEARREAD +CONFIRM	Class II

Riverain Technologies, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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