# K063153: Novapacs

- Pathway: 510(k) (Traditional)
- Applicant: Novarad Corp.
- Decided: Dec 7, 2006 after 52 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kodak DirectView (Carestream) PACS product: named in the summary without a submission number

## Most influential descendants
- K132853: Novapacs (2014), 6 descendants of its own
- 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

## Recalls of this device
- May 9, 2013 · Class II · Z-2151-2016: Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

## Indications for use
The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware. It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 51 OK approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis.

Source page: https://510kreport.com/device/K063153
Methodology: https://510kreport.com/methodology