# K150707: IntelePACS

- Pathway: 510(k) (Traditional)
- Applicant: Intelerad Medical Systems Incorporated
- Decided: May 27, 2015 after 69 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: 1 generation back to K083520 (2009). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083520: Intelepacs, Model Version 3.X.X, Intelerad Medical Systems Incorporated (2009) Summary page 4.

## Most influential descendants
- K192176: IntelePACS (2020), 0 descendants of its own
- K162141: Restore PACS (2016), 0 descendants of its own

## Indications for use
IntelePACS™ 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). Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians. Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.

Source page: https://510kreport.com/device/K150707
Methodology: https://510kreport.com/methodology