# K132316: Multiview

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Oct 30, 2013 after 97 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K211431: breastscape v1.0 (2021), 0 descendants of its own

## Indications for use
MultiView is a software application that is intended for use in processing. manipulating. and displaying magnetic resonance imaging (MRI) images as well as other multi-modality DICOM medical images and data that it receives from various sources (e.g. CT. US. secondary capture devices, scanners, imaging sources. and imaging gateways). MultiView provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis. These computer-aided and/or user-defined processing functions include artifact minimization, image subtractions, multi-planar reformats, and maximum intensity projections. It also includes the following automatic functions: physiological analysis tools, diffusion analysis, and segmenting of lesions. Multi View also provides tools for automated targeting for breast interventional procedures. Lossy compressed mamnmographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA. MultiView is typically used by trained professionals. including radiologists, technologists and clinicians and may provide information to be used for screening, diagnostic and interventional procedures. Patient management decisions should not be made solely on the results of MultiView analysis.

Source page: https://510kreport.com/device/K132316
Methodology: https://510kreport.com/methodology