Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611033

FEI Number

3002807138

Entity Name

HADECO, INC.

City/State/Country

KAWASAKI Kanagawa, JP

Establishment Address

2-7-11 ARIMA, MIYAMAE-KU, KAWASAKI Kanagawa 216-0003, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hadeco, Inc. (Owner Number: 8030313)

Owner / Operator Contact Address

2-7-11 Arima, Miyamae-ku, Kawasaki, JP-14 216-0003, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K915550

PMA Number

N/A

All Registered Proprietary Names

Smardop XT6 HD-307 Smartdop 30EX Smartdop XT SmartVLink software BiDop 3 CW Doppler probes ES100VX MiniDoppler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2016-06-16
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2009-01-13
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2009-01-13
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2014-11-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-01-13
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2009-01-13
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2009-01-13
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2009-01-13
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2009-01-13

Official Correspondent

Takuji Hakamada

US Agent Details

HEATHER BELL Business: KOVEN TECHNOLOGY, INC. Email: koven@koven.com Phone: (314) 5422101

Related Public Records

Same Entity

Hadeco, 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
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

Similar Registrations

Registration Number	Establishment Name	Location
1937397	KOVEN TECHNOLOGY, INC.	Saint Louis, MO, US
3006648308	SKIDMORE MEDICAL LIMITED	Bristol Bristol, City of, GB
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
1000393132	COOK INCORPORATED	ELLETTSVILLE, IN, US
1820334	Cook Incorporated	Bloomington, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611033. Last updated year: 2026. Please use registration number 9611033 when referencing this establishment in official correspondence.