# K132853: Novapacs

- Pathway: 510(k) (Traditional)
- Applicant: Novarad Corp.
- Decided: Oct 30, 2014 after 413 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 90 ancestors in all.
6 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)
- K063153: Novapacs, Novarad Corp. (2006) Summary page 4.
- K043194: Voxar 3D Product Family, Voxar Limited (2005) Summary page 4.
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 4.
- K072821: Vitrea 4DCT, Vital Images, Inc. (2008) Summary page 4.
- K103785: Mobile Mim, Mim Software, Inc. (2011) Summary page 4.

## Most influential descendants
- K160371: NovaPACS (2016), 5 descendants of its own
- 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

## Recalls of this device
- Aug 12, 2016 · Class II · Z-2659-2016: Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
- Nov 16, 2015 · Class II · Z-1613-2016: The SUV values that are being calculated in the PET/CT fusion tool are incorrect.

## 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. NovaPACS is not intended for diagnostic image review on a mobile platform. While NovaPACS 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/K132853
Methodology: https://510kreport.com/methodology