# K161341: Lifesys Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Lifetrack Medical Systems, Inc.
- Decided: Apr 5, 2017 after 327 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product, Erad, Inc. (2012) Summary page 4.

## Indications for use
LifeSys™ PACS is a Picture Archive and Communications software product used to receive pertinent radiology patient information and DICOM images and allow easy generation of a Radiology Report for distribution over a network. LifeSys™ PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images. LifeSys™ PACS is for hospitals, imaging centers, radiologists, radiology professional services providers and any user who requires and is granted access to patient image, demographic and report information. The LifeSys™ PACS viewer displays images from CT, computed radiography, MRI, nuclear medicine, PET, ultrasound, x-ray angiography, and x-ray fluoroscopy.

Source page: https://510kreport.com/device/K161341
Methodology: https://510kreport.com/methodology