Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614587

FEI Number

3006974930

Entity Name

MEDIS MEDICAL IMAGING SYSTEMS, B.V.

City/State/Country

LEIDEN Zuid-Holland, NL

Establishment Address

SCHUTTERSVELD 9, LEIDEN Zuid-Holland 2316 XG, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDIS HOLDING B.V. (Owner Number: 9039556)

Owner / Operator Contact Address

SCHUTTERSVELD 9, LEIDEN, NL-ZH 2316 XG, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140587

PMA Number

N/A

All Registered Proprietary Names

QIvus QCU-CMS QAngio XA Medis Suite MRCT 3DView QStrain QFlow 4D QFlow Medis Suite QMass

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2005-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2005-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-04-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

Vitalie Cojan Business: Medis Medical Imaging Systems Inc. Email: vcojan@medisimaging.com Phone: (919) 2787888

Related Public Records

Same Entity

MEDIS HOLDING B.V.

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
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
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

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.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Similar Registrations

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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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614587. Last updated year: 2026. Please use registration number 9614587 when referencing this establishment in official correspondence.