# K232641: Neorad Pacs (Neorad Pacs)

- Pathway: 510(k) (Traditional)
- Applicant: Everrtech Software Pvt, Ltd.
- Decided: Apr 10, 2024 after 224 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: 2 generations back to K182572 (2019). 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)
- K211863: eVolve PACS, Evolve Pacs, Inc. (2021) Summary page 4.

## Indications for use
NeoRad PACS is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software. NeoRad PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. NeoRad PACS, may also be integrated with the facility's Teleradiology Provider systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the NeoRad PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA.

Source page: https://510kreport.com/device/K232641
Methodology: https://510kreport.com/methodology