510(k) · Cleared
Recalled · 2011Imalux Niris Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imalux Corporation · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Nov 19, 2004 as substantially equivalent to K033783 (Imalux Coporation, 2004) after a 30-day review. Its family tree reaches back 2 generations to 1994. 14 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944523 (1994). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944523 Humphrey Oct (Optical Coherence Tomography) ScannerHumphrey, Inc. · 1994
- 1 generation backK033783 Imalux Oct Imaging SystemImalux Coporation · 2004
- This deviceK042894 Imalux Niris Imaging SystemImalux Corporation · 2004
- Descendant · cites it directly · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK160240 Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK171560 OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · cites it directly9descendants
- K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · 2 generations on6descendants
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 2015 · 3 generations on5descendants
- K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2016 · cites it directly3descendants
- K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944523 | Humphrey Oct (Optical Coherence Tomography) Scanner | Humphrey, Inc. | 1994 | — |
| −1 | K033783 | Imalux Oct Imaging System | Imalux Coporation | 2004 | — |
| 0 (this device) | K042894 | Imalux Niris Imaging System | Imalux Corporation | 2004 | — |
| +1 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| +2 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| +3 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
| +1 | K160240 | Perimeter Otis™ 1.0 Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2016 | — |
| +2 | K171560 | OTIS Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 20 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 |
|---|---|---|---|
| * | K033783 | Imalux Oct Imaging SystemSummary page 1…gally marketed device Device Name 510(k) Number Imalux OCT Imaging System K033783 D. Device Description The Imalux Niris Imaging System utilizes near infrared (NIR) light to create high… | 2004 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2011 | Not classified | Z-0934-2012 | Process control | During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112770 (Ninepoint Medical, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K033783.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Imalux Niris Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042894 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042894: Imalux Niris Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042894
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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