# K132586: Paxerapacs

- Pathway: 510(k) (Traditional)
- Applicant: Paxeramed
- Decided: Oct 31, 2013 after 76 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Paxera PALS is a scalable medical image and informatics system intended to receive, transmit, display, print and process digital images from medical image modality supporting the DICOM 3.0 standard, these modalities are Magnetic Resonance (MR), Computed Tomography (CT) Computed Radiography (CR), Digital X-Ray (DR), Digital Mammography (MG), X-Ray Angiography (XA), Ultrasound (US), Nuclear Medicine (NM), and Positron Emission Tomography (PT). The Paxera PACS workstation provides the user with the ability to display, manipulate, attach diagnostic reports, archive, transmit and print images using DICOM and other computer industry standard interfaces and standards. Mammography images intended for primary interpretation must be acquired for an FDA approved Full Field Digital Mammography (FDDM) device. In addition, the FDDM device must be able to provide to the Paxera PALS "for presentation" a viewable DICOM image as approved by FDA for primary interpretation. If images are sent to a film printer such printers must be FDA approved for diagnosis of digital mammography images. If digital mammography images are viewed on a display that display must be cleared by the FDA for primary diagnosis of digital mammography images. The Paxera PACS allows for integration with many open interfaces including DICOM, Web Client, and Archiving devices. The Paxera PACS server infrastructure software facilitate database management and image management, printing, HL-7 interfacing and all DICOM services such as Store/Retrieve, Query and Send. The Paxera PACS is intended for use by trained medical professionals including but not limited to, Radiologists, Physicians and Medical Technologists. It is the user's responsibility to ensure quality by taking measures to achieve the proper lighting conditions and image compression ratios consistent with the clinical requirements of the indented use.

Source page: https://510kreport.com/device/K132586
Methodology: https://510kreport.com/methodology