# K051081: Essenpacs

- Pathway: 510(k) (Traditional)
- Applicant: Cymed Engineering, Inc.
- Decided: May 12, 2005 after 15 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: 2 generations back to K010259 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031013: Infintt CO., LTD. Starpacs System, Infinitt Company (2003). Our reading of the summary gave K011013, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “STARPACS”.

## Indications for use
ESSENPACS is a software package intended for acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images (including mammographic images). It receives digital images and data from various sources (including CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K051081
Methodology: https://510kreport.com/methodology