510(k) · Cleared
ClearedKubtec Mozart (Xpert42)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kub Technologies, Inc. · MWP Cabinet, X-Ray System
Cleared on Jun 20, 2019 as substantially equivalent to K071233 (Kub Technologies, Inc., 2007) after a 176-day review. Its family tree reaches back 3 generations to 2002. 3 later devices descend from it.
- Decided
- Jun 20, 2019
- Review
- 176 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021113 (2002). 5 ancestors in all, the oldest K953404 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 2 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 1 generation backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- This deviceK183624 Kubtec Mozart (Xpert42)Kub Technologies, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK200756 Kubtec Mozart SupraKub Technologies, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK210955 Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK210956 Kubtec Mozart (XPERT42)Kub Technologies, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −2 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −1 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| 0 (this device) | K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019 | — |
| +1 | K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | 2020 | — |
| +2 | K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021 | — |
| +1 | K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 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 MWP? 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 MWP device
- #1 K202713 TrueView 100 Proscore 7.9 · 6 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 |
|---|---|---|---|
| * | K071233 | Xpert 40 Specimen Radiography SystemSummary page 5…me: Stationary X-ray System Predicate Device: Device Name: Kubtec XPERT 40 510(k) Number: K071233 Classification Class: II Regulation Number: 21 CFR 892.1680… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K200756 (Kub Technologies, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K071233.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MWP
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MWP
154in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWP
No recall names MWP since 2007.
Adverse event reports per year · MWP
1in 2025
MAUDE reports naming product code MWP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 5 | 104 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 154 | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MOZART(XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
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/K183624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183624: Kubtec Mozart (Xpert42).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183624
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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