# K103679: Axis Pacs, HMS Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Axis Health Care, LLC
- Decided: Mar 3, 2011 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
Longest line of descent: 5 generations back to K896095 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.

## Indications for use
axis PACS is a software application intended to perform operations relating to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information, axis PACS receives digital images and data from various modalities, including but not limited to; Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Fluoroscopy (RF), secondary screen captures devices, scanners, digitizers, or other imaging sources. It is intended for use by the physician to aid diagnosis and used by medical professionals whenever they require access to medical images and patient demographic information. Users have access to a variety of measurement tools and imnageprocessing to aid them in viewing digital images. This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images. axis PACS can integrate with a health care institution's or physician's office Health Information System (HIS) or a Radiology Information System (RIS) for a fully integrated electronic patient record. Typical users of axis PACS are trained medical professionals including radiologists, physicians, radiology technologists, and other clinicians.

Source page: https://510kreport.com/device/K103679
Methodology: https://510kreport.com/methodology