510(k) · Cleared
ClearedJazz Classic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jazz Imaging · LLZ System, Image Processing, Radiological
Cleared on Nov 21, 2024 as substantially equivalent to K110886 (Sota Precision Optics, Inc., 2011) after a 177-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Nov 21, 2024
- Review
- 177 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930527 (1993). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930527 Dental LinkEscan, Inc. · 1993
- 5 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 4 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 3 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 2 generations backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- 1 generation backK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
- This deviceK241495 Jazz ClassicJazz Imaging · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −5 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −4 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −3 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −2 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| −1 | K110886 | Clio/Cliosoft | Sota Precision Optics, Inc. | 2011 | — |
| 0 (this device) | K241495 | Jazz Classic | Jazz Imaging | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K110886 | Clio/CliosoftSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K110886 CLIO/CLIOSOFT LLZ Device D… | 2011 |
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 31 years and passes through 7 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 17 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Jazz Classic is a clinical software application that captures images and data from Jazz intraoral x-ray sensors and various imaging sources (e.g., radiographic devices, digital still/video capture devices, and generic image devices such as scanners). Jazz Classic enables the storage of images, clinical notes, and clinical exam data. Jazz Classic is intended to be used for general populations which includes use for pediatric populations.
It is intended to acquire, display, edit (e.g., resize, enhance), review, print, and distribute images using standard PC hardware. Jazz Classic is intended for diagnostic and non-diagnostic purposes by dental professionals trained to provide dental care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241495: Jazz Classic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241495
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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