510(k) · Decided
DecidedPerimeter Otis™ 1.0 Optical Coherence Tomography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimeter Medical Imaging, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on May 13, 2016 as substantially equivalent to K042894 (Imalux Corporation, 2004) and 1 other predicate after a 102-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- May 13, 2016
- Review
- 102 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944523 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK944523 Humphrey Oct (Optical Coherence Tomography) ScannerHumphrey, Inc. · 1994
- 2 generations backK033783 Imalux Oct Imaging SystemImalux Coporation · 2004
- 1 generation backK042894 Imalux Niris Imaging SystemImalux Corporation · 2004 · Recalled
- This deviceK160240 Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171560 OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK190404 OTIS Optical Coherence Tomography SYstemPerimeter Medical Imaging, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK203578 OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence…Perimeter Medical Imaging Ai, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2017 · cites it directly2descendants
- K190404OTIS Optical Coherence Tomography SYstemPerimeter Medical Imaging, Inc. · 2019 · 2 generations on1descendant
- K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging Ai, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944523 | Humphrey Oct (Optical Coherence Tomography) Scanner | Humphrey, Inc. | 1994 | — |
| −2 | K033783 | Imalux Oct Imaging System | Imalux Coporation | 2004 | — |
| −1 | K042894 | Imalux Niris Imaging System | Imalux Corporation | 2004 | 1 |
| 0 (this device) | K160240 | Perimeter Otis™ 1.0 Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2016 | — |
| +1 | K171560 | OTIS Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2017 | — |
| +2 | K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | 2019 | — |
| +3 | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence… | Perimeter Medical Imaging Ai, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K042894 | Imalux Niris Imaging SystemSummary page 6…tion: 21 CFR 892.1560 Product Code: NQQ Classification: Class II 3. Legally Marketed Predicate Devices Imalux OCT Imaging System, K033783 Imalux Niris™ Imaging System, K042894 4. Device Description The Perimeter Optical Tissue Imaging System (OTIS) 1.0 is an imaging tool for use on excised human tissue… | 2004 |
| * | K033783 | Imalux Oct Imaging SystemSummary page 6…o imaging system Regulatory Classification: 21 CFR 892.1560 Product Code: NQQ Classification: Class II 3. Legally Marketed Predicate Devices Imalux OCT Imaging System, K033783 Imalux Niris™ Imaging System, K042894 4. Device Description The Perimeter Optical Tissue Imaging System (OTIS) 1.0 is an imagin… | 2004 |
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 |
|---|---|---|---|
| K171560 | OTIS Optical Coherence Tomography System | 2017 | 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 22 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K171560 (Perimeter Medical Imaging, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K042894.
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. 2016, this device’s year, is highlighted.
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 OTIS 1.0 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-section, real-time depth visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160240: Perimeter Otis™ 1.0 Optical Coherence Tomography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160240
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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