510(k) · Cleared
ClearedOnco Trac Model 1, 2, 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Translational Sciences Corporation · LLZ System, Image Processing, Radiological
Cleared on Nov 18, 2011 as substantially equivalent to K081985 (Ge Medical Systems, LLC, 2008) after a 158-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 158 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945188 (1995). 17 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 4 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 3 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 2 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 1 generation backK081985 AW ServerGe Medical Systems, LLC · 2008 · Recalled
- This deviceK111642 Onco Trac Model 1, 2, 4Translational Sciences Corporation · 2011
- Descendant · cites it directly · 2 of its ownK142647 mint LesionMint Medical GmbH · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK220929 ExcelsiorMerit Cro, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK202229 AI MetricsAi Metrics, LLC · 2020
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 |
|---|---|---|---|---|---|
| −5 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −4 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −3 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −2 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −1 | K081985 | AW Server | Ge Medical Systems, LLC | 2008 | 5 |
| 0 (this device) | K111642 | Onco Trac Model 1, 2, 4 | Translational Sciences Corporation | 2011 | — |
| +1 | K142647 | mint Lesion | Mint Medical GmbH | 2015 | 3 |
| +2 | K220929 | Excelsior | Merit Cro, Inc. | 2022 | — |
| +2 | K202229 | AI Metrics | Ai Metrics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K081985 | AW ServerSummary page 1…Server Manufacturer: General Electric Medical Systems 5 10(k) Number: K081985 Confidential 13 OncoTracTM 5 10(k) '\\… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142647 | mint Lesion | 2015 | 2 |
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 16 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 6 of the 17 ancestors have a recall of any class.
- Of its descendants, K142647 (Mint Medical GmbH, 2015) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K081985.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
OncoTraCTM is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MMJ, measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in…
Read the full statement (138 words)
OncoTraCTM is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including CT and MMJ, measurement of lesions identified by trained users, tabulation of measurements, categorization of tumor response in accordance with user selected standards, and generation of a structured imaging report.
OncoTracTM is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. OncocTM does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.
OncoTracTM is not intended for use for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111642: Onco Trac Model 1, 2, 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111642
Report an extraction error
Are you the manufacturer?
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