510(k) · Cleared
ClearedMcKesson Radiology Mammography Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckesson Medical Imaging Company · LLZ System, Image Processing, Radiological
Cleared on Jan 6, 2015 as substantially equivalent to K103385 (Hologic, Inc., 2011) after a 98-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jan 6, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- 2 generations backK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- 1 generation backK103385 Securview DX Diagnostic WorkstationHologic, Inc. · 2011 · Recalled
- This deviceK142850 McKesson Radiology Mammography PlusMckesson Medical Imaging Company · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| −2 | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003 | Hologic, Inc. | 2006 | — |
| −1 | K103385 | Securview DX Diagnostic Workstation | Hologic, Inc. | 2011 | 1 |
| 0 (this device) | K142850 | McKesson Radiology Mammography Plus | Mckesson Medical Imaging Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103385 | Securview DX Diagnostic WorkstationSummary page 4…Classification Product Code: LLZ Device Class: Class 11 Classification Panel: Radiology Devices Predicate Devices: Hologic, Inc. SecurView DX Diagnostic Workstation (K103385) Intended Use / Indications for Use McKesson Radiology Mammography Plus™ (“Mammography Plus™), is an accessory to McKesson Radi… | 2011 |
| † | K140909 | Mckesson Radiology | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K103385.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
McKesson Radiology Mammography Plus™ (“Mammography Plus™), is an accessory to McKesson Radiology Station™, a component of McKesson Radiology™. McKesson Radiology is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology™ includes a suite of…
Read the full statement (203 words)
McKesson Radiology Mammography Plus™ (“Mammography Plus™), is an accessory to McKesson Radiology Station™, a component of McKesson Radiology™. McKesson Radiology is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology™ includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications.
McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossless compressed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging, Ultrasound, and Nuclear Medicine , as well as medical images obtained from other DICOM-compliant modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using cleared monitors intended for mammography display.
McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142850: McKesson Radiology Mammography Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142850
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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