510(k) · Cleared
ClearedTOMi Scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photonicare, Inc. · QJG Device System, Imaging, Tympanic Membrane And Middle Ear
Cleared on Dec 5, 2019 as substantially equivalent to K133209 (Diagnostic Photonics, Inc., 2014) after a 153-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 5, 2019
- Review
- 153 days
- Class
- Class II
- Product code
- QJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944523 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944523 Humphrey Oct (Optical Coherence Tomography) ScannerHumphrey, Inc. · 1994
- 2 generations backK033783 Imalux Oct Imaging SystemImalux Coporation · 2004
- 1 generation backK133209 Foresee (4C) Imaging SystemDiagnostic Photonics, Inc. · 2014
- This deviceK191804 TOMi ScopePhotonicare, Inc. · 2019
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 | K133209 | Foresee (4C) Imaging System | Diagnostic Photonics, Inc. | 2014 | — |
| 0 (this device) | K191804 | TOMi Scope | Photonicare, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 QJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K133209 | Foresee (4C) Imaging SystemSummary page 4…(Primary) Model Name: Foresee (4C) Imaging System Common Name: Optical Coherence Tomography Scanner 510(k) # K133209 Manufacturer: Diagnostic Photonics, Inc. Submitted: October 17, 2013 Reference Device:… | 2014 |
| † | K123821 | Aio HD Otoscope | 2013 |
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 25 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QJG devicesQJG Device System, Imaging, Tympanic Membrane And Middle Ear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QJG
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QJG
Too few QJG 510(k)s in any year since 2007 to give a median.
Recalls per year · QJG
No recall names QJG since 2007.
Adverse event reports per year · QJG
No MAUDE report names QJG 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 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TOMi Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and
fluid or air within the middle ear space. In the presence of middle ear fluid, the TOMi Scope is used to visualize the fluid
density. The TOMi Scope is also used to provide surface images of the ear canal and tympanic membrane.
It is indicated for use in children and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191804: TOMi Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191804
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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