FDA.reportPublic FDA data

QMAPP

Primary DI
08719689142124
Brand
QMAPP
Company
Fysicon B.V.
Model
QMAPP HEMO
Catalog number
01076101
Device description
The QMAPP Hemo, a full-blown hemodynamic monitoring system, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making operation intuitive (reporting functionalities) in order to optimize the workflow. QMAPP Hemo is user-friendly and is connected with a single cable and mounted to a standard DIN-rail on the X-ray or operating table, which will increase the operational space and freedom of movement in the lab as shorter cables can be used. A QMAPP amplifier is hot swappable by disconnecting a single cable, without loss of patient or exam data.
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241766000QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV2025-08-27MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719689142124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719689142124087196891421248719689142124

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac catheterization monitoring systemAn assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor and a graphic recorder, and a slave monitor including patient interface modules in the catheterization laboratory. The system is used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches.

Regulatory Flags#

DUNS number
404866654
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720938410284QMAPPQMAPP Cardiac Output Inline temperature probe018020572026-06-26
08719689142131QMAPP QMAPP HEMO LT010761032026-05-19
08719689142162QMAPP QMAPP GO010761102026-05-19
08719689142179QMAPP QMAPP PCM010761002026-05-19
08719689142209QMAPP Lead set (10 pcs) IEC, Grabber, Radiolucent (4 Lim015670022026-05-19
08719689142216QMAPP QMAPP 10 Lead ECG trunck cable, IEC 165 cm015670312026-05-19
08719689142223QMAPP QMAPP 10 Lead ECG trunk cable, IEC 320 cm015670802026-05-19
08719689142247QMAPP QMAPP 5 Lead ECG trunk cable, IEC 165 CM015670562026-05-19
08719689142254QMAPP QMAPP 5 Lead ECG trunk cable, IEC 320 cm015670812026-05-19
08719689142261QMAPP 5 Lead (IEC) Radiopaque Lead wire set with grabber015670582026-05-19
08719689142322QMAPPQMAPP IBP connection cable BD, Argon - Merit DTX P015670222026-05-19
08719689142339QMAPPQMAPP IBP Connection cable - Namic, Angiodynamics 015670642026-05-19
08719689142346QMAPPQMAPP IBP Connection cable - Namic, Angiodynamics 015670782026-05-19
08719689142353QMAPPQMAPP IBP Connection cable - Abbott (320 cm)015670452026-05-19
08719689142360QMAPPQMAPP IBP Connection Cable - Merit Meritrans (320 018020302026-05-19
08719689142377QMAPPQMAPP IBP Connection cable - Utah, ADI (320 cm)018020322026-05-19
08719689142384QMAPPQMAPP IBP Connection cable - Medex Logical (320 cm018020342026-05-19
08719689142391QMAPPQMAPP IBP Connection Cable - Edwards, Baxter (320 015670712026-05-19
08719689142407QMAPPQMAPP Dual 'Y' - IBP connection cable015670342026-05-19
08719689142414QMAPPQMAPP SpO2 connection cable 300cm015670832026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.MWI2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
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B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27