# K032533: Intelepacs

- Pathway: 510(k) (Traditional)
- Applicant: Intelerad Medical Systems, Inc.
- Decided: Oct 16, 2003 after 62 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: 3 generations back to K010259 (2001). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023460: Pacsplus, Medical Standard Co., Ltd. (2003)

## Most influential descendants
- K070080: Intelepacs (2007), 5 descendants of its own
- K110332: Clearcanvas Ris / Pacs (2011), 4 descendants of its own
- K191530: StoneChecker (2019), 1 descendant of its own
- K213660: RadAlly (2023), 0 descendants of its own
- K202084: DeepLook PRECISE (2021), 0 descendants of its own

## Indications for use
IntelePACS is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K032533
Methodology: https://510kreport.com/methodology