Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011162972

FEI Number

3011162972

Entity Name

SONELE INC.

City/State/Country

Markham Ontario, CA

Establishment Address

2751 John St, Markham Ontario L3R 2Y8, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SONELE Inc. (Owner Number: 10051244)

Owner / Operator Contact Address

46 Riviera Drive, Markham, CA-ON L3R 5M1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AbClo ExactVu High Resolution Micro-Ultrasound System Transrectal Reusable Needle Guide for EV29L transducer - 18GA Exact EV5C Transducer Transrectal Reusable Needle Guide for EV29L transducer for 16 GA Needle Exact EV9C Transducer Exact EV9C Transducer Transrectal Reusable Needle Guide for EV29L transducer for 16 GA Needle Exact EV5C Transducer Transrectal Reusable Needle Guide for EV29L transducer - 18GA UHF46-20 Transducer for Sonosite LX Ultrasound System ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF48 ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF22 ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF70 Molli 2 Molli 2 Tablet Molli 2 Wand Transrectal Reusable Needle Guide for EV29L transducer - 18GA Exact EV9C Transducer Exact EV5C Transducer ExactVu High Resolution Micro-Ultrasound System Transrectal Reusable Needle Guide for EV29L transducer for 16 GA Needle ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF22 ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF70 ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF48 ExactVu High Resolution Micro-Ultrasound System Transrectal Reusable Needle Guide for EV29L transducer for 16 GA Needle Exact EV9C Transducer Transrectal Reusable Needle Guide for EV29L transducer - 18GA Exact EV5C Transducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2025-04-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-04-23
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2025-04-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-04-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-04-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-27
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2017-06-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-04-23
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-08-14
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2025-04-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-04-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-04-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-04-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-04-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-05-24
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2018-05-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-05-24

Official Correspondent

Eric Reider

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

SONELE Inc.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011162972. Last updated year: 2026. Please use registration number 3011162972 when referencing this establishment in official correspondence.