Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2221819

FEI Number

2221819

Entity Name

MINDRAY DS USA, Inc.

City/State/Country

Mahwah, NJ, US

Establishment Address

800 MACARTHUR BLVD., Mahwah, NJ 07430, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mindray DS USA, Inc. (Owner Number: 10025908)

Owner / Operator Contact Address

800 MacArthur Blvd, Mahwah, NJ 07430, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200015

PMA Number

N/A

All Registered Proprietary Names

Z5 Diagnostic Ultrasound System BC3200 Hematology Analyzer TE Air Diagnostic Ultrasound System HyBase V6 Operating Table HyBase V6 Operation Table accessories V90 Electronic Vaporizers A8 Anesthesia Delivery System A9 Anesthesia Delivery System DC-3 Ultrasound System SC-CAL Plus Calibrator Accutorr 7 Rosie 4 BC-5390 Auto Hematology Analyzer MX7 Diagnostic Ultrasound System MX8 Diagnostic Ultrasound System ME8 Diagnostic Ultrasound System BC-3D control DP-20 Digital Ultrasonic Diagnostic Imaging System DP-30 Digital Ultrasonic Diagnostic Imaging System Passport Series Patient Monitor, 12m, 17m and T1 BS-400/CLC 720 Chemistry Analyzer Accutorr 3 Monitor Rosebud M6 Ultrasound System Imagyn I9 Diagnostic Ultrasound System Resona I9T Diagnostic Ultrasound System Resona I9 Diagnostic Ultrasound System MX7 Diagnostic Ultrasound System MX8 Diagnostic Ultrasound System BS-480 Chemistry Analyzer Yumizen C560 Chemistry Analyzer CLC720i Chemistry Analyzer DC-8 Diagnostic Ultrasound System DC-8 EXP Diagnostic Ultrasound System BA-800M Chemistry Analyzer BA-800M ISE KIT Chemistry Analyzer Z60 Diagnostic Ultrasound System Z6 Diagnostic Ultrasound System M-5LEO(I) LYSE M-5LEO(II) LYSE M-53LH LYSE M-30CFL LYSE Passport 8/12 Monitor cPM 8/12 DC-88 Diagnostic Ultrasound System DC-90 Diagnostic Ultrasound System DC-80 Diagnostic Ultrasound System ViewMate Ultrasound System SV900 Ventilator SV700 Ventilator DP-6900 ZS3 Elite Ultrasound Systems Z.one pro Ultrasound System ZS3KP Elite Ultrasound Systems DC-T6 Ultrasound System Resona A20 Diagnostic Ultrasound System ViewMate Multi Ultrasound System (VMM-ICE-01) ViewMate Multi Ultrasound System (VMM-ICE-02) Resona I8 Diagnostic Ultrasound System Hepatus 5 Diagnostic Ultrasound System Hepatus 6 Diagnostic Ultrasound System A7 Anesthesia System M7 Diagnostic Ultrasound System A3 Anesthesia Delivery System A5 Anesthesia Delivery System PROBE CLEANSER M-30R RINSE M-30P PROBE CLEANSER M-30 E-Z CLEANSER SV70 Ventilator Consona N6 Diagnostic Ultrasound System A5 Anesthesia System A4 Anesthesia System Consona N9 Diagnostic Ultrasound System TE X Diagnostic Ultrasound System TE X Lite Diagnostic Ultrasound System BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70 BeneVision Distributed Monitoring System (DMS) with Telemetry TM80, TM70 BeneVision Central Monitoring System with Telemetry - TD60 and TM80, and accessories VS-900c Fukuda VSM Accutorr 7 Vital Signs Monitors VS 8 Vital Signs Monitors VS 9 Vital Signs Monitors VS 8A M-53D Diluent M-30D Diluent BS200 Chemistry Analyzer Pointe c2000 Chemistry Analyzer A7 Anesthesia System HyBase V6 Operating Table Accessories(Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit) Operating Room Accessories Table Tray HyBase V6 Operating Table (Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit) ViewMate Multi Ultrasound System MX3 Diagnostic Ultrasound System MX6 Diagnostic Ultrasound System DC-40 Diagnostic Ultrasound System TE7 / TE5 / TE7 Max / TE9 Ultrasound System DP-50 Expert Digital Ultrasonic Diagnostic Imaging System ePM Series Monitor ePM 10A Monitor ePM 12M Monitor ePM 12MA Monitor ePM 10M Monitor ePM 15M Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-13
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-12-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-16
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-11-12
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2021-08-06
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2021-08-06
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-08-06
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-08-06
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-08-06
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-08-06
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2021-08-06
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2021-08-06
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2021-08-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-12-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-12-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-12-10
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2023-06-14
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2023-06-14
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2023-06-14
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2023-06-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-02-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-02-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-02-08
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2018-02-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-02-08
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2023-06-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2014-12-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-12-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-12-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-12-12
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-12-12
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-12-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-12-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-12-12
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-12-12
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-12-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-12-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-12-12
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-12-10
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-12-10
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-12-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-12-10
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-04-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-04-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-04-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-08-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2014-12-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-12-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-12-10
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-12-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-12-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-12-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-12-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-12-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-12-12
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-06-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-06-14
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-06-14
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-06-14
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2023-06-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-13
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2025-05-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-01-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-06-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-06-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-11-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-03-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-03-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-03-06
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-12-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-11-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-12-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-12-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-12-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2018-02-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-02-08
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2018-02-08
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2018-02-08
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2018-02-08
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2018-02-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-07-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-07-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-07-02
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-02-25
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2013-02-25
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2013-02-25
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-02-25
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-02-25
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2013-02-25
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-02-25
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2013-02-25
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-02-25
JCB	Detergent	Pathology	Class 1	864.4010	2025-05-30
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-06-09
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2018-02-08
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2018-02-08
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2018-02-08
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-02-08
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2018-02-08
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-02-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-02
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-06-01
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2026-06-01
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2026-06-01
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-06-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-06-01
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2026-06-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-06-01
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2019-12-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-12-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-12-12
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-12-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-12-12
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-12-12
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2019-12-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-05-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-27
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-05-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-05-27
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-05-27
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-06-09
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2025-05-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-12-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-12-10
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-12-10
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-12-10
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2015-12-01
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-11-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-08-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-08-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-08-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-11-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-11-13
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-11-13
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-11-13
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2020-11-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-11-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-11-13
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-11-13

Official Correspondent

James Clifford

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mindray DS USA, 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
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-05	Datascope Corp	2	Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2221819. Last updated year: 2026. Please use registration number 2221819 when referencing this establishment in official correspondence.