# K171754: NovaPACS

- Pathway: 510(k) (Traditional)
- Applicant: Novarad Corporation
- Decided: Jul 28, 2017 after 45 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 99 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160371: NovaPACS, Novarad Corporation (2016) Summary page 5.
- K133910: Nordicbrainex, Nordicneurolab (2014) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Sep 10, 2019 · Class II · Z-2956-2020: The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization refer

## 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, including mammography. 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 or fMRI. 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. NovaPACS is intended for providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in a clinically useful context.

Source page: https://510kreport.com/device/K171754
Methodology: https://510kreport.com/methodology