510(k) · Cleared
ClearedImprovis Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Dental Partners, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 10, 2010 as substantially equivalent to K082623 (Televere Systems, 2009) and 1 other predicate after a 152-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Nov 10, 2010
- Review
- 152 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930527 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK930527 Dental LinkEscan, Inc. · 1993
- 3 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 2 generations backK061035 Tigerview ProfessionalTelevere Systems · 2006
- 1 generation backK082623 Visix ImagingTelevere Systems · 2009
- This deviceK101654 Improvis Imaging SystemAmerican Dental Partners, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −3 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −2 | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| −1 | K082623 | Visix Imaging | Televere Systems | 2009 | — |
| 0 (this device) | K101654 | Improvis Imaging System | American Dental Partners, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K082623 | Visix ImagingSummary page 2…C.F.R. § 892.2050 Device Classification: Class II Predicate Devices: Televere Systems Visix Imaging K082623 Televere Systems TigerView Professional K061035 Device Description Improvis Imaging is a so… | 2009 |
| * | K061035 | Tigerview ProfessionalSummary page 2…Devices: Televere Systems Visix Imaging K082623 Televere Systems TigerView Professional K061035 Device Description Improvis Imaging is a software package that allows dental clinicians to acquire images from standard dental… | 2006 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K082623.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images. Improvis Imaging is written using three…
Read the full statement (102 words)
Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images.
Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher.
Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101654: Improvis Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101654
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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