Lifesys Pacs

LifeSys PACS archives patient imaging studies and supports radiology report creation and distribution. Its viewer displays DICOM images from modalities including CT, MRI, radiography,…

Registry build 21.09.26

LifeSys PACS archives patient imaging studies and supports radiology report creation and distribution. Its viewer displays DICOM images from modalities including CT, MRI, radiography, nuclear medicine, PET, ultrasound, angiography and fluoroscopy.

LifePACS provides worklists, image receipt and archiving, report editing and integration tools. LifeView supplies image viewing and multiple-monitor support for diagnostic review within authorized clinical workflows.

Listed Item

LIFESYS PACS v2

Display Conditions

Physicians interpret the images and associated information. The display quality, ambient lighting and surrounding conditions must suit clinical review, with the software operating on specified commercial computer components.

16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LLZ
Manufacturer City Province Registered as Device types
Shantou Institute OF Ultrasonic Instruments Co., Ltd. Shantou Guangdong Contract manufacturer 8
iRay Imaging Technology (Haining) Limited Haining Zhejiang Contract manufacturer 6
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Carestream Health, Inc., Global R&D Center Shanghai Shanghai Specification developer 8
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4

Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological

Record

Regulatory record for Lifesys Pacs
Listed by Lifetrack Medical Systems Private Ltd., Singapore
FDA product code LLZ
Device type System, Image Processing, Radiological
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Manufacturer
510(k) K161341
Record published 2017-07-13
Record revised 2023-10-18 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Lifesys Pacs
Catalogue number Size Status
2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imagegrid Radiology Viewer System Candelis, Inc. 173
Tims System Foresight Imaging, LLC 159
System, Image Processing, Radiological Biomet Microfixation 146
RamSoft Ramsoft, Inc. 65
Joints Medstrat 62
OrthoView Meridian Technique Ltd 54
IPS KLS-Martin L.P. 48
NovaPACS Novarad Corp. 42
PointCloud Knee Instruments Unik Orthopedics, Inc 34
DTX Studio™ Clinic Nobel Biocare AB 34
Eaglesoft Patterson Technology Center 33
Medtronic Navigation Medtronic Navigation, Inc. 26

Showing 12 of 1,109. All products under System, Image Processing, Radiological

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K161341 2017-04-05

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