510(k) · Cleared
ClearedMultiview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 30, 2013 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 30, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK132316 MultiviewHologic, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK211431 breastscape v1.0Olea Medical · 2021
Most influential descendants
Showing 1 of 1 · See all- K211431breastscape v1.0Olea Medical · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132316 | Multiview | Hologic, Inc. | 2013 | — |
| +1 | K211431 | breastscape v1.0 | Olea Medical | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211431 | breastscape v1.0 | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211431 (Olea Medical, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (189 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132316: Multiview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132316
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026