Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005156333

FEI Number

3005156333

Entity Name

RIVERAIN TECHNOLOGIES

City/State/Country

MIAMISBURG, OH, US

Establishment Address

3130 SOUTH TECH BLVD., MIAMISBURG, OH 45342, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Riverain Technologies (Owner Number: 9066125)

Owner / Operator Contact Address

3130 SOUTH TECH BLVD., --, Miamisburg, OH 45342, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P000041

All Registered Proprietary Names

ClearRead CT CAC ClearRead Bone Suppression SoftView ClearRead Bone Suppress ClearRead Xray Bone Suppress ClearRead CT ClearRead +Confirm ClearRead Enhanced ClearRead Xray Confirm ClearRead Xray Enhanced ClearRead +Detect ClearRead Xray Detect OnGuard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-12-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-02-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-11-14
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2016-11-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-02-19
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2005-05-10

Official Correspondent

Jonathan Jackson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Riverain Technologies

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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

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3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
2134213	CANON MEDICAL INFORMATICS, INC.	MINNETONKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005156333. Last updated year: 2026. Please use registration number 3005156333 when referencing this establishment in official correspondence.