510(k) · Cleared
ClearedForesee (4C) Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Photonics, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Mar 17, 2014 as substantially equivalent to K033783 (Imalux Coporation, 2004) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Mar 17, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944523 (1994). 3 ancestors in all. 1 later device descends from it, 1 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 deviceK133209 Foresee (4C) Imaging SystemDiagnostic Photonics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK191804 TOMi ScopePhotonicare, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191804TOMi ScopePhotonicare, Inc. · 2019 · cites it directly0descendants
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) | K133209 | Foresee (4C) Imaging System | Diagnostic Photonics, Inc. | 2014 | — |
| +1 | K191804 | TOMi Scope | Photonicare, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K033783 | Imalux Oct Imaging SystemSummary page 1…21 CFR 892.1560 Product Code: NQQ Classification: Class 11 3. Predicate Devices: Imalux OCT Imaging System - K033783 Michelson Diagnostics VivoSight Topical OCT System - K093520 4. Indications far Use Statement: The Foresee (4C) Imaging S… | 2004 |
| * | K093520 | Vivosight Topical Oct SystemSummary page 1…NQQ Classification: Class 11 3. Predicate Devices: Imalux OCT Imaging System - K033783 Michelson Diagnostics VivoSight Topical OCT System - K093520 4. Indications far Use Statement: The Foresee (4C) Imaging System is intended to be used as an imaging tool in the evalua… | 2010 |
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 |
|---|---|---|---|
| K191804 | TOMi Scope | 2019 | 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 20 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191804 (Photonicare, Inc., 2019) has gone furthest, with 0 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. 2014, 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 Foresee (4C) Imaging System is indicated for use as an imaging tool in the
evaluation of external 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/K133209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133209: Foresee (4C) Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133209
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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