510(k) · Cleared
ClearedMiiS Horus Eye Anterior Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimaging Integrated Solution, Inc (Miis) · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jan 14, 2020 as substantially equivalent to K170470 (Medimaging Integrated Solution, Inc (Miis), 2017) after a 57-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jan 14, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003376 (2001). 8 ancestors in all, the oldest K954782 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- 4 generations backK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- 3 generations backK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- 2 generations backK120982 Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis) · 2012
- 1 generation backK170470 Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017
- This deviceK193188 MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| −4 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| −3 | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | Optomed OY | 2011 | — |
| −2 | K120982 | Digital Eye-Fundus Camera | Medimaging Integrated Solutions, Inc. (Miis) | 2012 | — |
| −1 | K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017 | — |
| 0 (this device) | K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 HJO? 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 HJO device
- #1 K253834 Visuref 600score 13.1 · 8 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 |
|---|---|---|---|
| * | K170470 | Digital Eye Anterior CameraSummary page 5…e, Slit lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO, HKI Predicate Device: K170470 Trade/Device Name: MiiS Horus+ Scope DEA 200 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicrosco… | 2017 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, 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 | 1 | — | 0 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non- invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193188: MiiS Horus Eye Anterior Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193188
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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