Xper Information Management System

The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types…

Registry build 21.09.26

The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device.

10manufacturers in China registered for this device type
9catalogue numbers in this listing
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DQK
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Dongguan Ergotron Precision Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd Shenzhen Guangdong Manufacturer 7
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC Shanghai Shanghai Specification developer 6
Shenzhen Carewell Electronics Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for Xper Information Management System
Listed by Philips Medical Systems Nederland B.V., Netherlands
FDA product code DQK
Device type Computer, Diagnostic, Programmable
Device class Class 2
Regulation 21 CFR 870.1425
Establishment Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published 2017-07-01
Record revised 2023-09-26 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Xper Information Management System
Catalogue number Size Status
2.3 In distribution
6 In distribution
2.1 In distribution
2.2 In distribution
2.6 In distribution
2.5 In distribution
5 In distribution
2.4 In distribution
1.5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EnSite™ St. Jude Medical 177
Computer, Diagnostic, Programmable St. Jude Medical 57
MediGuide™ St. Jude Medical 41
AcQMap Acutus Medical, Inc. 38
WorkMate Claris™ St. Jude Medical 35
iLab Ultrasound Imaging System Boston Scientific Corporation 32
Rhythmia™ Mapping System Boston Scientific Corporation 31
Sentinel Spacelabs Healthcare (Washington), Inc 28
Rhythmia HDx™ Boston Scientific Corporation 26
EnSite Precision™ St. Jude Medical 23
PathfinderSL Spacelabs Healthcare (Washington), Inc 22
Labsystem™ PRO Boston Scientific Corporation 19

Showing 12 of 228. All products under Computer, Diagnostic, Programmable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K252645 2025-10-24
K233853 2024-03-14
K223918 2023-06-08
K180940 2018-10-24

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Xper Information Management System
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Philips Medical Systems Nederland B.V. UDI-DI 2024-05-02 Class II Component design/selection Potential for pressure wave data synchronization from two devices may not be correct. 391 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer