REDSTONE HEALTHCARE LLC

FDA Device Registration & Listing · Lake Forest, IL, US · Registration 3010952312

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010952312
FEI Number
3010952312
Entity Name
REDSTONE HEALTHCARE LLC
City/State/Country
Lake Forest, IL, US
Establishment Address
825 S Waukegan Road, A8 #161, Lake Forest, IL 60045, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Redstone Healthcare LLC (Owner Number: 10048374)
Owner / Operator Contact Address
825 S Waukegan Road, A8 #161, Lake Forest, IL 60045, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K051263
PMA Number
N/A

All Registered Proprietary Names

ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND EPIQ Cvx and Series Diagnostic Ultrasound System; Affiniti Cvx and Series Diagnostic Ultrasound System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-01-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-01-06
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-01-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-01-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-01-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-01-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-02-09
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-02-09
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2026-02-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-02-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-02-09
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-05-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-15
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-05-07

Official Correspondent

Keith Rubenstein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Redstone Healthcare LLC
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
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number Establishment Name Location
3029744051 LYSIS HEALTHCARE GMBH Graz Steiermark, AT
3014574557 ADECHOTECH NAVEIL Loir-et-Cher, FR
3012081348 THE SENTINEL IMAGING GROUP, INC Clarks Summit, PA, US
3025786376 ACO HEALTHCARE CO., LTD. Taoyuan City, TW
3004752776 Compumedics Germany GmbH Singen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010952312. Last updated year: 2026. Please use registration number 3010952312 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.