# K211863: eVolve PACS

- Pathway: 510(k) (Traditional)
- Applicant: Evolve Pacs, Inc.
- Decided: Aug 12, 2021 after 57 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 K182572 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182572: InstaRISPACS / InstaZFP / InstaMobi v5.0, Meddiff Technologies Pvt., Ltd. (2019) Summary page 4.

## Most influential descendants
- K232641: Neorad Pacs (Neorad Pacs) (2024), 0 descendants of its own

## Indications for use
eVolve 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. eVolve 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. eVolve PACS, may also be integrated with the facility’s Teleradiology Provider’s systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of a 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 eVolve 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. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.

Source page: https://510kreport.com/device/K211863
Methodology: https://510kreport.com/methodology