# K192176: IntelePACS

- Pathway: 510(k) (Traditional)
- Applicant: Intelerad Medical Systems Incorporated
- Decided: Apr 2, 2020 after 234 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K083520 (2009). 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)
- K150707: IntelePACS, Intelerad Medical Systems Incorporated (2015) Summary page 4.

## Recalls of this device
- Sep 5, 2026 · Class II · Z-0186-2027: Following a Chromium-based web-browser, report and displayed images may not match.
- Oct 17, 2025 · Class II · Z-0723-2026: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field 
- Feb 5, 2025 · Class II · Z-1208-2025: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT stu

## Indications for use
IntelePACS is a software application 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). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. When used with a mobile device, IntelePACS is suitable for diagnostic image review only on tested devices as specified in Intelerad product documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.

Source page: https://510kreport.com/device/K192176
Methodology: https://510kreport.com/methodology