# K160371: NovaPACS

- Pathway: 510(k) (Traditional)
- Applicant: Novarad Corporation
- Decided: Oct 14, 2016 after 247 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: 12 generations back to K913770 (1991). 91 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132853: Novapacs, Novarad Corp. (2014) Summary page 4.
- K103785: Mobile Mim, Mim Software, Inc. (2011) Summary page 4.

## Most influential descendants
- K171754: NovaPACS (2017), 4 descendants of its own
- K231662: Aid-U (2024), 1 descendant of its own
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K250039: HPACS (2025), 0 descendants of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own

## Indications for use
NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. Mobile devices are not intended to replace a full workstation and should be used only when there is no access to a workstation. They are not to be used for mammography. Mobile devices are used for diagnosis of medical images from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. For a list of compatible mobile platforms see NovaPACS Diagnostic Viewer User Manual. While NovaPACS full workstation provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application.

Source page: https://510kreport.com/device/K160371
Methodology: https://510kreport.com/methodology