# K070080: Intelepacs

- Pathway: 510(k) (Traditional)
- Applicant: Intelerad Medical Systems, Inc.
- Decided: Jan 24, 2007 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032533: Intelepacs, Intelerad Medical Systems, Inc. (2003) Summary page 1.
- K023460: Pacsplus, Medical Standard Co., Ltd. (2003) Summary page 2.
- K061672: Synapse Mip/MPR Image Visualization Software Obliquus, Fujifilm Medical Systems U.S.A, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K181460: OnePacs System (2018), 0 descendants of its own

## Recalls of this device
- Oct 27, 2008 · Not classified · Z-1885-2009: Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.
- Oct 27, 2008 · Not classified · Z-1884-2009: Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.

## Indications for use
IntelePACSTM is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and 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. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K070080
Methodology: https://510kreport.com/methodology