# K051813: Ultrapacs

- Pathway: 510(k) (Traditional)
- Applicant: Ultrarad Corporation
- Decided: Aug 15, 2005 after 41 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: 4 generations back to K010259 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042311: Pacspartner, Medical Standard Co., Ltd. (2004) Summary page 1.
- K041500: Starpacs Orthopedics System, Infinitt Co., Ltd. (2004) Summary page 1.

## Indications for use
UltraPACSTM system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, RIF 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. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K051813
Methodology: https://510kreport.com/methodology