510(k) · Cleared
ClearedOTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimeter Medical Imaging Ai, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Feb 25, 2021 as substantially equivalent to K190404 (Perimeter Medical Imaging, Inc., 2019) after an 80-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Feb 25, 2021
- Review
- 80 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944523 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK944523 Humphrey Oct (Optical Coherence Tomography) ScannerHumphrey, Inc. · 1994
- 5 generations backK033783 Imalux Oct Imaging SystemImalux Coporation · 2004
- 4 generations backK042894 Imalux Niris Imaging SystemImalux Corporation · 2004 · Recalled
- 3 generations backK160240 Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2016
- 2 generations backK171560 OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. · 2017
- 1 generation backK190404 OTIS Optical Coherence Tomography SYstemPerimeter Medical Imaging, Inc. · 2019
- This deviceK203578 OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence…Perimeter Medical Imaging Ai, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944523 | Humphrey Oct (Optical Coherence Tomography) Scanner | Humphrey, Inc. | 1994 | — |
| −5 | K033783 | Imalux Oct Imaging System | Imalux Coporation | 2004 | — |
| −4 | K042894 | Imalux Niris Imaging System | Imalux Corporation | 2004 | 1 |
| −3 | 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 | — |
| −1 | K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | 2019 | — |
| 0 (this device) | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence… | Perimeter Medical Imaging Ai, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K190404 | OTIS Optical Coherence Tomography SYstemSummary page 4…cho imaging system Regulatory Classification: 21 CFR 892.1560 Product Code: NQQ Classification: Class II 3. Legally Marketed Predicate Devices Perimeter OTIS™ 2.0, K190404 4. Device Description The Perimeter OTIS™ 2.1 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.1 is ba… | 2019 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2021, 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 2.1 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-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
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/K203578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203578: OTIS 2.1 Optical Coherence Tomography System, THiA 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/K203578
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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