510(k) · Cleared
ClearedNinesMeasure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nines, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 25, 2021 as substantially equivalent to K162484 (Philips Medical Systems Nederland B.V., 2017) after a 148-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.
- Decided
- Feb 25, 2021
- Review
- 148 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 35 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- 1 generation backK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- This deviceK202990 NinesMeasureNines, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240740 qCT LN QuantQure.Ai Technologies · 2024
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- 1 generation backK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- This deviceK202990 NinesMeasureNines, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K240740qCT LN QuantQure.Ai Technologies · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −5 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −4 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −3 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −2 | K151283 | Lung Analysis Software | Vital Images, Inc. | 2015 | — |
| −1 | K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K202990 | NinesMeasure | Nines, Inc. | 2021 | — |
| +1 | K240740 | qCT LN Quant | Qure.Ai Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K162484 | Lung Nodule Assessment and Comparison Option (LNA)Summary page 4…diological Regulatory Class: Class II Product Code: LLZ Predicate Device: Philips Medical Systems Nederland B.V.’s Lung Nodule Assessment and Comparison Option (LNA) (K162484) Device Description NinesMeasure is a semi-automatic, diagnostic patient imaging tool used to measure the size of selected pulm… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240740 | qCT LN Quant | 2024 | 0 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 35 ancestors have a recall of any class.
- Of its descendants, K240740 (Qure.Ai Technologies, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K162484.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
NinesMeasure is a semi-automatic tool indicated for use by trained radiologists to aid in the analysis and review of adult thoracic CT images. NinesMeasure provides quantitative information about pulmonary nodule size on a single study or over the time course of several thoracic studies by providing long and short axis diameter measurements in the axial plane. Based on analysis of DICOM images and provided input from a radiologist, indicating the…
Read the full statement (156 words)
NinesMeasure is a semi-automatic tool indicated for use by trained radiologists to aid in the analysis and review of adult thoracic CT images. NinesMeasure provides quantitative information about pulmonary nodule size on a single study or over the time course of several thoracic studies by providing long and short axis diameter measurements in the axial plane.
Based on analysis of DICOM images and provided input from a radiologist, indicating the location of the pulmonary nodule, the device uses artificial intelligence algorithms to automatically perform the measurements, and allows the axial measurements to be displayed and reviewed. NinesMeasure is limited for use on solid pulmonary nodules.
The device is intended to be used as a measurement tool by a trained radiologist and is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm a diagnosis. The device does not alter the original medical image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202990: NinesMeasure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202990
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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