PROBO MEDICAL, INC.

FDA Device Registration & Listing · Fishers, IN, US · Registration 3012411160

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
3012411160
FEI Number
3012411160
Entity Name
PROBO MEDICAL, INC.
City/State/Country
Fishers, IN, US
Establishment Address
9715 Kincaid Dr Ste 1000, Fishers, IN 46037, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Probo Medical, Inc. (Owner Number: 10051673)
Owner / Operator Contact Address
9715 Kincaid Dr Suite 1000, Fishers, IN 46037, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K210416
PMA Number
N/A

All Registered Proprietary Names

ACUSON Redwood Diagnostic Ultrasound System M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9Premium Diagnostic Ultrasound System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2026-03-25
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-03-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-03-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-03-25
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-03-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-03-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Probo Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3036255956 PROBO MEDICAL, INC. Oakville Ontario, CA

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

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3007329020 Cardinal Health 200, LLC El Paso, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012411160. Last updated year: 2026. Please use registration number 3012411160 when referencing this establishment in official correspondence.
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