# K241223: eRAD PACS

- Pathway: 510(k) (Traditional)
- Applicant: Erad, Inc.
- Decided: Oct 31, 2024 after 183 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: 6 generations back to K954678 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product, Erad, Inc. (2012) Summary page 5.

## Indications for use
eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces. eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images. eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information. The eRAD PACS viewer displays images from DICOM compliant modalities and other devices including CT, computed and digital radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light systems. Lossy compressed images and digitized film images must not be used for primary diagnosis of mammography studies. When displaying mammography images for clinical interpretation, only monitors having regulatory clearance for mammography interpretation should be used.

Source page: https://510kreport.com/device/K241223
Methodology: https://510kreport.com/methodology