510(k) · Cleared
ClearedLimbus Contour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Limbus Ai, Inc. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Oct 9, 2024 as substantially equivalent to K230575 (Limbus Ai, Inc., 2023) after a 106-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Oct 9, 2024
- Review
- 106 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954874 (1996). 56 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations between
- 3 generations backK173420 Radiomics App v1.0Microsoft Corp. · 2017
- 2 generations backK201232 Limbus ContourLimbus Ai, Inc. · 2020
- 1 generation backK230575 Limbus ContourLimbus Ai, Inc. · 2023
- This deviceK241837 Limbus ContourLimbus Ai, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 5 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 4 generations backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- 3 generations backK173420 Radiomics App v1.0Microsoft Corp. · 2017
- 2 generations backK201232 Limbus ContourLimbus Ai, Inc. · 2020
- 1 generation backK230575 Limbus ContourLimbus Ai, Inc. · 2023
- This deviceK241837 Limbus ContourLimbus Ai, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −11 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −10 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −9 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −8 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −7 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −6 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −5 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| −4 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| −3 | K173420 | Radiomics App v1.0 | Microsoft Corp. | 2017 | — |
| −2 | K201232 | Limbus Contour | Limbus Ai, Inc. | 2020 | — |
| −1 | K230575 | Limbus Contour | Limbus Ai, Inc. | 2023 | — |
| 0 (this device) | K241837 | Limbus Contour | Limbus Ai, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 QKB? 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 QKB device
- #1 K191928 AccuContourscore 32.8 · 14 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 |
|---|---|---|---|
| * | K230575 | Limbus ContourSummary page 5…uct Classification Code: QKB III. PREDICATE DEVICE Predicate Manufacturer: Limbus AI, Inc. Predicate Trade Name: Limbus Contour Predicate 510(k): K230575 No reference devices were used in this submission. IV. DEVICE DESCRIPTION Limbus Contour is a stand-alone software medical devi… | 2023 |
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 28 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 12 of the 56 ancestors have a recall of any class.
How does its category compare?
All QKB devicesQKB Radiological Image Processing Software For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QKB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKB
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKB
No recall names QKB since 2007.
Adverse event reports per year · QKB
No MAUDE report names QKB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | 244 | 0 | 0 |
| 2021 | 9 | 120 | 0 | 0 |
| 2022 | 7 | 162 | 0 | 0 |
| 2023 | 7 | 111 | 0 | 0 |
| 2024 | 6 | 173 | 0 | 0 |
| 2025 | 6 | 170 | 0 | 0 |
| 2026 | 9 | 179 | 0 | — |
What is it indicated for?
Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display…
Read the full statement (118 words)
Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning.
Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios:
Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning.
Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up.
Localization and definition of healthy anatomical structures.
Limbus Contour is not intended for use with digital mammography.
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/K241837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241837: Limbus Contour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241837
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