QMAPP

Primary DI
08719689142179
Brand
QMAPP
Company
Fysicon B.V.
Model
QMAPP PCM
Catalog number
01076100
Device description
The QMAPP PCM, a basic 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 PCM 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 procedure 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
08719689142179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719689142179087196891421798719689142179

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719689142124QMAPP QMAPP HEMO010761012026-05-19
08719689142131QMAPP QMAPP HEMO LT010761032026-05-19
08719689142162QMAPP QMAPP GO010761102026-05-19
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
08719689142469QMAPPReusable NiBP Cuff, Infant (Orange), 8-13 cm018530012026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213252MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213238MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-04-23
10884838113777MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
10884838115092MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
10884838129938MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2026-01-06
14250892908509JaegerJaeger Medical GmbHMWI2025-11-24
14250892908936JaegerJaeger Medical GmbHMWI2025-11-24
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
10884838111407MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2025-05-30
10884838117874MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120805MR Patient Care Infant NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120812MR Patient Care Pediatric NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120829MR Patient Care Small Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120836MR Patient Care Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120843MR Patient Care Adult-Long NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120867MR Patient Care Large Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120874MR Patient Care Large Adult-Long NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120881MR Patient Care Thigh NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120942MR Patient Care Neonatal Size 1 NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120959MR Patient Care Neonatal Size 2 NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22